The following data is part of a premarket notification filed by Bioptigen, Inc. with the FDA for Enfocus 2300, Enfocus 4400.
| Device ID | K150722 |
| 510k Number | K150722 |
| Device Name: | EnFocus 2300, EnFocus 4400 |
| Classification | Ophthalmoscope, Ac-powered |
| Applicant | BIOPTIGEN, INC. 633 DAVIS DRIVE, SUITE 480 Morrisville, NC 27560 |
| Contact | Tammy B Carrea |
| Correspondent | Tammy B Carrea BIOPTIGEN, INC. 633 DAVIS DRIVE, SUITE 480 Morrisville, NC 27562 |
| Product Code | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-20 |
| Decision Date | 2015-12-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857691006114 | K150722 | 000 |
| 00857691006107 | K150722 | 000 |
| 00857691006091 | K150722 | 000 |
| 00857691006084 | K150722 | 000 |
| 00857691006343 | K150722 | 000 |
| 00857691006336 | K150722 | 000 |