BABYLOG 8000 PLUS
FDA 510(k) clearance K974176 · decided 1998-06-17
Clearance details
- K-number
- K974176
- Device name
- BABYLOG 8000 PLUS
- Applicant
- Drager, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-11-06
- Decision date
- 1998-06-17
- Days to decision
- 223 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Telford, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Babylog 8000 plus with software version 5.n. Neonatal Respirator-Continuous Ventilator recall (Z-0515-06) | Draeger Medical, Inc. | 2006-02-14 |