HJGClass I
System, Reading, Television, Closed-Circuit
21 CFR 886.5820 / Ophthalmic
HJG is the FDA product code for System, Reading, Television, Closed-Circuit, a class I device type, regulated under 21 CFR 886.5820. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- HJG
- Device name
- System, Reading, Television, Closed-Circuit
- Regulation
- 21 CFR 886.5820
- 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
- 8
- Ingested recalls
- 0
Clearances, product code HJG
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1989 | 5 |
| 1992 | 2 |
| 1994 | 1 |
Applicants with the most clearances
Product code HJG| Applicant | Clearances |
|---|---|
| Coburn Optical Ind., Inc. | 5 |
| Gracefully Yours, Inc. | 1 |
| Innoventions, Inc. | 1 |
| Mentor O & O, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Acula Technology Corp
- Beijing Hongdee Corporation
- Enhanced Vision Systems, Inc.
- Freedom Scientific BLV Group, LLC.
- ICU Eyecare Solutions Inc.
- M/S Tarun Enterprises
- Rehan Electronics
- Shaoxing Undis Medical Technology Company Limited
- Wenzhou Topsight Eyewear Co.,Ltd
- Zoomax (USA) Inc.
- Zoomax Technology Co., Limited
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
