SENTEC DIGITAL MONITOR MODEL #SDM— 510(k) K041548
Substantially EquivalentSentec, Inc.
FDA 510(k) clearance K041548 for SENTEC DIGITAL MONITOR MODEL #SDM, Substantially Equivalent on 2004-08-09. Applicant: Sentec, Inc.. Device class: 2.
Clearance details
- Applicant
- Sentec, Inc.
- Product code
- Code LKD
- Device class
- Class 2
- Regulation
- 21 CFR 868.2480
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Egale, WI, US
Recent devices under product code LKD
view all- K232516 — Sentec Digital Monitoring System (SDMS) tCOM+
- K151329 — SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet
- K131253 — PERIFLUX 6000
- K110474 — PHILIPS INTELLIVUE TCG10
- K101690 — SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE
Recalls naming K041548
K-number listed on FDA's recall record- Z-2592-2023 — Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each package contains 3 changers; and Membrane Changer Insert, REF MC-I, each package contains 5 inserts. All are components of the Sentec Digital Monitoring System (SDMS).
- Z-1980-2023 — V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).
- Z-1134-2021 — SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuous, noninvasive patient monitoring of carbon dioxide partial pressure (PCo2), oxygen partial pressure (POs), functional oxygen saturation (PsO2), and pulse rate (PR), using either a single digital sensor (V-Sign Sensor 2 or OxiVenT sensor).
- Z-2152-2019 — SenTec Membrane Changer (reloadable) [9 pcs] - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.
- Z-2153-2019 — SenTec Standard Starter Set with and without Service Gas (2 changers each) - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.
- Z-2154-2019 — SenTec Neonatal Starter Set with and without Service Gas (2 Chargers each) - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.
- Z-2155-2019 — SenTec Membrane Changer Set (1 charger plus 1 insert) - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.
- Z-2156-2019 — SenTec Membrane Changer Insert [5 pcs - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.]
- Z-0088-2017 — SDMS (SenTec Digital Monitoring System)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K041548.
Data sourced from openFDA. This site is unofficial and independent of the FDA.