MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300— 510(k) K031741
Substantially EquivalentAlaris Medical Systems, Inc.
FDA 510(k) clearance K031741 for MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300, Substantially Equivalent on 2004-02-09. Applicant: Alaris Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Alaris Medical Systems, Inc.
- Product code
- Code CCK
- Device class
- Class 2
- Regulation
- 21 CFR 868.1400
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code CCK
view allMore clearances from Alaris Medical Systems, Inc.
view all- K043299 — MEDLEY PCA MODULE, MODEL 8120
- K041241 — MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600
- K032233 — MEDLEY PCA MODULE, MODEL 8120
- K032147 — SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES
- K030459 — MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM (MMS)
Adverse events under product code CCK
product code CCK- Death
- 3
- Malfunction
- 11,428
- Total
- 11,431
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K031741
K-number listed on FDA's recall record- Z-2443-2019 — Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933
- Z-0455-2016 — Alaris EtCO2 Module, Model 8300. A capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR).
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K031741.
Data sourced from openFDA. This site is unofficial and independent of the FDA.