HJG — System, Reading, Television, Closed-Circuit Class I
FDA product code HJG covers "System, Reading, Television, Closed-Circuit", a Class I medical device regulated under 21 CFR 886.5820. Submissions are reviewed by the Ophthalmic panel. At least 8 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HJG
- Device Class
- Class I
- Regulation Number
- 886.5820
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K933633 | gracefully yours | LOW-VISION READING AID, HELPMATE 2020, VISION-AIDE, LV HELPMATE | February 22, 1994 |
| K915340 | mentor o and o | MENTOR HORIZON LOW VISION MAGNIFIER | March 30, 1992 |
| K920069 | innoventions | MAGNI-CAM | March 2, 1992 |
| K892347 | coburn optical ind | MAGNILINK SYSTEM 101 | May 26, 1989 |
| K892348 | coburn optical ind | MAGNILINK SYSTEM 201 | May 26, 1989 |
| K892349 | coburn optical ind | MAGNILINK SYSTEM 209 | May 26, 1989 |
| K892351 | coburn optical ind | MAGNILINK SYSTEM 602 | May 26, 1989 |
| K892350 | coburn optical ind | MAGNILINK SYSTEM 402/5 | May 26, 1989 |