COHERENT FUNDUSL RETINAL CAMERA
FDA 510(k) clearance K822908 · decided 1983-01-05
Clearance details
- K-number
- K822908
- Device name
- COHERENT FUNDUSL RETINAL CAMERA
- Applicant
- Coherent Medical Division
- Decision
- Substantially Equivalent
- Date received
- 1982-09-30
- Decision date
- 1983-01-05
- Days to decision
- 97 days
- Clearance type
- Traditional
- Product code
- HKI
- Device class
- 2
- Regulation number
- 886.1120
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 (P830054/S022) | Coherent Medical Division | 1989-08-29 |
| NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 (P830054/S021) | Coherent Medical Division | 1988-08-30 |
| NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 (P830054/S020) | Coherent Medical Division | 1987-12-01 |
| NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 (P830054/S019) | Coherent Medical Division | 1987-07-21 |
| NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 (P830054/S018) | Coherent Medical Division | 1987-05-19 |
| NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 (P830054/S017) | Coherent Medical Division | 1987-03-31 |
| NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 (P830054/S015) | Coherent Medical Division | 1986-12-01 |
| NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 (P830054/S009) | Coherent Medical Division | 1986-11-07 |