VIEWMATE SYSTEM
FDA 510(k) clearance K071028 · decided 2007-05-01
Clearance details
- K-number
- K071028
- Device name
- VIEWMATE SYSTEM
- Applicant
- Ep Medsystems
- Decision
- Substantially Equivalent
- Date received
- 2007-04-11
- Decision date
- 2007-05-01
- Days to decision
- 20 days
- Clearance type
- Special
- Product code
- ITN
- Device class
- 1
- Regulation number
- 890.3675
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- West Berlin, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Y.E.S. POWERED WHEELCHAIR, MODEL T200 (K032669) | Yeou Eir Shuen Machinery Co., Ltd. | 2003-11-12 |
| COUNTER-ROTATION SYSTEM (K821256) | The Langer Group | 1982-06-23 |
Recalls involving this device
No recalls on record reference this clearance.