MODEL 200
FDA 510(k) clearance K830468 · decided 1983-04-12
Clearance details
- K-number
- K830468
- Device name
- MODEL 200
- Applicant
- Western Laboratories Corp.
- Decision
- Substantially Equivalent
- Date received
- 1983-02-15
- Decision date
- 1983-04-12
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- FTZ
- Device class
- 1
- Regulation number
- 886.4445
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Mchenry, IL, 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 |
|---|---|---|
| SUN BED BY VERRE ET QUARTZ UVA-FRANCE (K833229) | H & M Douglas Enterprises, Inc. | 1984-01-27 |
Recalls involving this device
No recalls on record reference this clearance.