The following data is part of a premarket notification filed by Bioptigen, Inc. with the FDA for Enfocus 2300, Enfocus 4400.
| Device ID | K162783 |
| 510k Number | K162783 |
| Device Name: | EnFocus 2300, EnFocus 4400 |
| Classification | Tomography, Optical Coherence |
| Applicant | Bioptigen, Inc. 633 Davis Drive Morrisville, NC 27560 |
| Contact | Ravi Kommineni |
| Correspondent | Ravi Kommineni Bioptigen, Inc. 633 Davis Drive Morrisville, NC 27560 |
| Product Code | OBO |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-03 |
| Decision Date | 2016-12-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857691006039 | K162783 | 000 |