CONPHAR-SCHIOETZ TONOMETER
FDA 510(k) clearance K813619 · decided 1982-02-24
Clearance details
- K-number
- K813619
- Device name
- CONPHAR-SCHIOETZ TONOMETER
- Applicant
- Conphar, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-12-29
- Decision date
- 1982-02-24
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- HKY
- Device class
- 2
- Regulation number
- 886.1930
- 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 |
|---|---|---|
| iCare ST500 (TA04) (K241447) | Icare Finland OY | 2024-09-27 |
| Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318) (K233516) | Reichert, Inc. | 2024-05-01 |
| CATS-L Tonometer™ Prism (K234037) | Cats Tonometer, LLC | 2024-02-09 |
| Applanation Tonometer HT-5000 (K232143) | Huvitz Co., Ltd. | 2023-10-23 |
| iCare IC200 (K220852) | Icare Finland OY | 2022-10-06 |
| 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.