DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500— 510(k) K040831
Substantially EquivalentDatex-Ohmeda, Inc.
FDA 510(k) clearance K040831 for DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500, Substantially Equivalent on 2004-09-02. Applicant: Datex-Ohmeda, Inc.. Device class: 2.
Clearance details
- Applicant
- Datex-Ohmeda, Inc.
- Product code
- Code DPZ
- Device class
- Class 2
- Regulation
- 21 CFR 870.2710
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Louisville, CO, US
Recent devices under product code DPZ
view allMore clearances from Datex-Ohmeda, Inc.
view allRecalls naming K040831
K-number listed on FDA's recall record- Z-2026-2023 — TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs; b) REF TS-AP-25, 25 pcs
- Z-2031-2023 — TruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE; Oximeter, Ear
- Z-2032-2023 — TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological, patient(with arrhythmia detection or alarms)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K040831.
Data sourced from openFDA. This site is unofficial and independent of the FDA.