OPHTHALMIC PROJECTOR
FDA 510(k) clearance K921214 · decided 1992-06-11
Clearance details
- K-number
- K921214
- Device name
- OPHTHALMIC PROJECTOR
- Applicant
- Luneau Ophtalmologie SA
- Decision
- Substantially Equivalent
- Date received
- 1992-03-13
- Decision date
- 1992-06-11
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- HOS
- Device class
- 1
- Regulation number
- 886.1680
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Chartres Cedex, FR
- 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 |
|---|---|---|
| WIRELESS CHART PROJECTOR,HCP-W 721 (K936200) | Canon USA, Inc. | 1994-09-28 |
| MARCO CP-600 AUTO CHART PROJECTOR/CP-1 CHART PROJE (K930443) | Marco Ophthalmic, Inc. | 1993-07-06 |
| BURTON PROJECTOR HEAD - MODEL 6000-H (K924784) | R.H. Burton Co. | 1993-04-05 |
| WOODLYN OPHTHALMIC PROJECTOR (K890992) | Woodlyn, Inc. | 1989-05-17 |
| BAUSCH & LOMB ACCU-CHART 3 ACUITY PROJECTOR (K862519) | Bausch & Lomb, Inc. | 1986-07-23 |
| MILLER/NADLER GLARE TESTER (K812706) | Mosebach Electric & Supply | 1981-11-16 |
| ULTRAMATIC PROJECT-O-CHART OPHTH. PROJ (K811180) | American Optical Corp. | 1981-05-15 |
| PROJECTOR, ACCU-CHART ACUITY (K781658) | Bausch & Lomb, Inc. | 1978-10-17 |
Recalls involving this device
No recalls on record reference this clearance.