BLEASE700/900 SERIES VENTILATORS
FDA 510(k) clearance K112729 · decided 2012-06-11
Clearance details
- K-number
- K112729
- Device name
- BLEASE700/900 SERIES VENTILATORS
- Applicant
- Spacelabs Healthcare
- Decision
- Substantially Equivalent
- Date received
- 2011-09-20
- Decision date
- 2012-06-11
- Days to decision
- 265 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Nederland, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Spacelabs Pediatric Flow Sensor Kit, PN: 376-0561-00. This kit is for Spacelabs Healthcare recall (Z-1458-2015) | Del Mar Reynolds Medical, Ltd. | 2015-04-20 |