QUANTITATIVE SENTINEL SYSTEM
FDA 510(k) clearance K993008 · decided 1999-12-06
Clearance details
- K-number
- K993008
- Device name
- QUANTITATIVE SENTINEL SYSTEM
- Applicant
- Marquette Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-09-07
- Decision date
- 1999-12-06
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- HGM
- Device class
- 2
- Regulation number
- 884.2740
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Annapolis, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GE Healthcare Centricity Perinatal (formerly Quantitative Sentinel) System - Alert and Rem recall (Z-0456-2009) | GE Healthcare Integrated IT Solutions | 2008-12-03 |
| Centricity Perinatal (formerly Quantitative Sentinel) System - Fluid Total Precision softw recall (Z-0112-2009) | GE Healthcare Integrated IT Solutions | 2008-10-15 |
| GE Healthcare Centricity Perinatal (formerly QS) System - PFILS (Patient File Server) soft recall (Z-2037-2008) | GE Healthcare Integrated IT Solutions | 2008-07-30 |