F 900
FDA 510(k) clearance K022054 · decided 2002-08-06
Clearance details
- K-number
- K022054
- Device name
- F 900
- Applicant
- C.S.O. S.R.L.
- Decision
- Substantially Equivalent
- Date received
- 2002-06-24
- Decision date
- 2002-08-06
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- HKY
- Device class
- 2
- Regulation number
- 886.1930
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Williamsville, NY, US
- Third-party review
- No
- Expedited review
- No
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| iCare HOME2 (K211355) | Icare Finland OY | 2022-01-25 |
| CATS®-D Tonometer Prism (K203850) | Cats Tonometer, LLC | 2021-06-14 |
| Icare HOME Tonometer (K200966) | Icare Finland OY | 2020-05-07 |
| Icare ic200 (K190316) | Icare Finland OY | 2020-01-14 |
| Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q (K191314) | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 2019-12-19 |
| Applanation tonometer AT-2 (K182491) | Takagi Seiko Co., Ltd. | 2018-12-10 |
| AT 030 (K180839) | Carl Zeiss Meditec, AG | 2018-06-07 |
Recalls involving this device
No recalls on record reference this clearance.