DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWARE
FDA 510(k) clearance K022740 · decided 2002-11-14
Clearance details
- K-number
- K022740
- Device name
- DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWARE
- Applicant
- Datex-Ohmeda
- Decision
- Substantially Equivalent
- Date received
- 2002-08-19
- Decision date
- 2002-11-14
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- MLD
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Needham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Datex-Ohmeda S/5 Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A softwa recall (Z-1994-2009) | GE Medical Systems Information Tecnology | 2009-09-01 |
| Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5 recall (Z-1995-2009) | GE Medical Systems Information Tecnology | 2009-09-01 |