ACCUTORR V MONITOR, MODEL 0998-00-2000
FDA 510(k) clearance K091068 · decided 2009-05-08
Clearance details
- K-number
- K091068
- Device name
- ACCUTORR V MONITOR, MODEL 0998-00-2000
- Applicant
- Datascope Corp., Patient Monitoring Division
- Decision
- Substantially Equivalent
- Date received
- 2009-04-14
- Decision date
- 2009-05-08
- Days to decision
- 24 days
- Clearance type
- Special
- Product code
- DXN
- Device class
- 2
- Regulation number
- 870.1130
- 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 |
|---|---|---|
| SmarTemp Probe Covers with the Accutorr V Monitor; Rx only. Mindray DS USA, Inc. Mahway, N recall (Z-1396-2010) | Mindray DS USA, Inc., dba Datascope Patient Monitoring | 2010-04-15 |