Datex-Ohmeda S/5 Critical Care Monitor with L-ICU02 and L-ICU02A Software
FDA 510(k) K021376 · Datex-Ohmeda
510(k) numberK021376
Submission
- Device name
- Datex-Ohmeda S/5 Critical Care Monitor with L-ICU02 and L-ICU02A Software
- Applicant
- Datex-Ohmeda
Needham, MA, US - Received
- May 1, 2002
- Decision date
- July 24, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DSI – Detector And Alarm, Arrhythmia
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
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Questions and answers
When was Datex-Ohmeda S/5 Critical Care Monitor with L-ICU02 and L-ICU02A Software cleared by the FDA?
Datex-Ohmeda S/5 Critical Care Monitor with L-ICU02 and L-ICU02A Software (K021376) received a 510(k) decision of Substantially Equivalent on July 24, 2002, 84 days after the submission was received.
What is the product code of K021376?
The FDA product code is DSI – Detector And Alarm, Arrhythmia, a Class II (moderate risk) device regulated under 21 CFR 870.1025.