SPECTABLE FRAME MAGNIFYING BRILLETTE
FDA 510(k) clearance K844657 · decided 1984-12-11
Clearance details
- K-number
- K844657
- Device name
- SPECTABLE FRAME MAGNIFYING BRILLETTE
- Applicant
- Pro Design Intl. AS
- Decision
- Substantially Equivalent
- Date received
- 1984-11-29
- Decision date
- 1984-12-11
- Days to decision
- 12 days
- Clearance type
- Traditional
- Product code
- HOJ
- Device class
- 1
- Regulation number
- 886.1810
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- New York, NY, 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 |
|---|---|---|
| TANGENT SCREEN (K873919) | Richmond Products, Inc. | 1987-10-28 |
| CHART PROJECTOR (K821081) | Medical Equipment Designs, Inc. | 1982-06-14 |
Recalls involving this device
No recalls on record reference this clearance.