Datex-Ohmeda S/5 Critical Care Monitor with L-ICU05 and L-ICU05A Software
FDA 510(k) K071889 · GE Healthcare
510(k) numberK071889
Submission
- Device name
- Datex-Ohmeda S/5 Critical Care Monitor with L-ICU05 and L-ICU05A Software
- Applicant
- GE Healthcare
Needham, MA, US - Received
- July 9, 2007
- Decision date
- May 19, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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-ICU05 and L-ICU05A Software cleared by the FDA?
Datex-Ohmeda S/5 Critical Care Monitor with L-ICU05 and L-ICU05A Software (K071889) received a 510(k) decision of Substantially Equivalent on May 19, 2008, 315 days after the submission was received.
What is the product code of K071889?
The FDA product code is DSI – Detector And Alarm, Arrhythmia, a Class II (moderate risk) device regulated under 21 CFR 870.1025.