DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES
FDA 510(k) clearance K992323 · decided 1999-11-01
Clearance details
- K-number
- K992323
- Device name
- DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES
- Applicant
- Datex-Ohmeda, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-07-12
- Decision date
- 1999-11-01
- Days to decision
- 112 days
- Clearance type
- Traditional
- Product code
- MLD
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Tewksburt, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Datex-Ohmeda Cardiocap/5 Patient Monitors recall (Z-0143-04) | Datex-Ohmeda Inc | 2004-07-20 |