The following data is part of a premarket notification filed by Topcon Healthcare Solutions, Inc. with the FDA for Glaucoma Module.
| Device ID | K200954 |
| 510k Number | K200954 |
| Device Name: | Glaucoma Module |
| Classification | System, Image Management, Ophthalmic |
| Applicant | Topcon Healthcare Solutions, Inc. 111 Bauer Drive Oakland, NJ 07436 |
| Contact | Ramya Sundaram |
| Correspondent | Maureen O'connell O'Connell Regulatory Consultants, Inc. 44 Oak Street Stoneham, MA 02180 |
| Product Code | NFJ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-09 |
| Decision Date | 2020-08-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850003069135 | K200954 | 000 |