VERGE VIDEOMETER
FDA 510(k) clearance K962148 · decided 1996-12-20
Clearance details
- K-number
- K962148
- Device name
- VERGE VIDEOMETER
- Applicant
- Verg, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-06-03
- Decision date
- 1996-12-20
- Days to decision
- 200 days
- Clearance type
- Traditional
- Product code
- FXN
- Device class
- 1
- Regulation number
- 878.4160
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Winnipeg, Manitoba, CA
- 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 |
|---|---|---|
| WOUND MEASURING & MONITORING DEVICE (K131596) | Woundvision, LLC | 2013-12-11 |
| PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0 (K130165) | Advanced Planimetric Services, LLC | 2013-08-30 |
| SILHOUETTE, MODEL 1000.01 (K070426) | Aranz Medical Limited | 2007-06-29 |
Recalls involving this device
No recalls on record reference this clearance.