PASSPORT V MONITOR, MODEL 0998-00-6100
FDA 510(k) clearance K091834 · decided 2009-07-15
Clearance details
- K-number
- K091834
- Device name
- PASSPORT V MONITOR, MODEL 0998-00-6100
- Applicant
- Datascope Corp., Patient Monitoring Division
- Decision
- Substantially Equivalent
- Date received
- 2009-06-22
- Decision date
- 2009-07-15
- Days to decision
- 23 days
- Clearance type
- Special
- Product code
- MHX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mahwh, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Passport V Monitor, Multiparameter Patient Monitor(with Arrhythmia Detection and Alarms) I recall (Z-1280-2015) | Mindray DS USA, Inc. dba Mindray North America | 2015-03-16 |
| Passport V Monitor: Mindray, North America. Mindray DS USA, Inc. Mahwah, NJ 07430. Intende recall (Z-1785-2010) | Mindray DS USA, Inc., dba Datascope Patient Monitoring | 2010-06-10 |