HOEClass I
Caliper, Ophthalmic
21 CFR 886.4350 / Ophthalmic
HOE is the FDA product code for Caliper, Ophthalmic, a class I device type, regulated under 21 CFR 886.4350. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- HOE
- Device name
- Caliper, Ophthalmic
- Regulation
- 21 CFR 886.4350
- Device class
- Class I
- Review panel
- Ophthalmic
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 7
- Ingested recalls
- 0
Clearances, product code HOE
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1979 | 1 |
| 1980 | 1 |
| 1981 | 1 |
| 1982 | 2 |
| 1988 | 1 |
Applicants with the most clearances
Product code HOE| Applicant | Clearances |
|---|---|
| Accutome, Inc. | 1 |
| Aztec Medical Products, Inc. | 1 |
| CooperVision, Inc. | 1 |
| Design Research Assoc., Inc. | 1 |
| Edward Weck, Inc. | 1 |
| Koi, Inc. | 1 |
| V. Mueller O.V. Baxter Healthcare Corp. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.