SUNSOR ULTRAVIOLET METER
FDA 510(k) clearance K934728 · decided 1994-07-28
Clearance details
- K-number
- K934728
- Device name
- SUNSOR ULTRAVIOLET METER
- Applicant
- Sunsor, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-09-29
- Decision date
- 1994-07-28
- Days to decision
- 302 days
- Clearance type
- Traditional
- Product code
- EAQ
- Device class
- 2
- Regulation number
- 872.6350
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Pittsburgh, PA, 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 |
|---|---|---|
| LIGHT, EXAMINING, DENTAL, ULTRA VIOLET (K770685) | Parker Laboratories, Inc. | 1977-04-26 |
Recalls involving this device
No recalls on record reference this clearance.