NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01
FDA 510(k) clearance K080175 · decided 2008-06-09
Clearance details
- K-number
- K080175
- Device name
- NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01
- Applicant
- Datascope Corp., Patient Monitoring Division
- Decision
- Substantially Equivalent
- Date received
- 2008-01-24
- Decision date
- 2008-06-09
- Days to decision
- 137 days
- Clearance type
- Abbreviated
- Product code
- BSZ
- Device class
- 2
- Regulation number
- 868.5160
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mahwh, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Datascope AS3000 Anesthesia System; Mindray, North America. The AS3000 Anesthesia Delivery recall (Z-1313-2010) | Mindray DS USA, Inc., dba Datascope Patient Monitoring | 2010-04-08 |
| AS3000 Anesthesia Delivery System. Datascope Patient Monitoring; A Mindray Global Company. recall (Z-0319-2009) | Mindray DS USA, Inc., dba Datascope Patient Monitoring | 2008-12-05 |