3160 MRI PATIENT MONITORING SYSTEM
FDA 510(k) clearance K053462 · decided 2006-01-18
Clearance details
- K-number
- K053462
- Device name
- 3160 MRI PATIENT MONITORING SYSTEM
- Applicant
- Invivo Corporation
- Decision
- Substantially Equivalent
- Date received
- 2005-12-13
- Decision date
- 2006-01-18
- Days to decision
- 36 days
- Clearance type
- Special
- Product code
- MWI
- Device class
- 2
- Regulation number
- 870.2300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Orlando, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Radio used in the Precess MRI Patient Monitoring System. 3160 (Precess) and HE97B, 94044, recall (Z-0113-2012) | Invivo Corporation | 2011-10-27 |
| 3.7 V Li-Polymer Battery, used in Precess MRI Compatible Patient Monitoring System and Ach recall (Z-0971-2009) | Invivo Corporation | 2009-02-06 |