MOTILITY VISUALIZATION SYSTEM
FDA 510(k) clearance K031169 · decided 2003-12-12
Clearance details
- K-number
- K031169
- Device name
- MOTILITY VISUALIZATION SYSTEM
- Applicant
- Sierra Scientific Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-04-14
- Decision date
- 2003-12-12
- Days to decision
- 242 days
- Clearance type
- Traditional
- Product code
- FFX
- Device class
- 2
- Regulation number
- 876.1725
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AR ManoShield, MSS-3599, 10 pack. FGS: MSS-3599, Individual package label: LBL-110275-03, recall (Z-0135-2012) | Sierra Scientific Instruments Inc | 2011-10-28 |