The following data is part of a premarket notification filed by Phoenix Technology Group, Inc. Dba Phoenix Clinical with the FDA for Phoenix Clinical Icon.
| Device ID | K170527 |
| 510k Number | K170527 |
| Device Name: | Phoenix Clinical ICON |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | Phoenix Technology Group, Inc. Dba Phoenix Clinical 6630 Owens Drive Pleasanton, CA 94588 |
| Contact | Christopher A. Henderson |
| Correspondent | Christopher A. Henderson Phoenix Technology Group, Inc. Dba Phoenix Clinical 6630 Owens Drive Pleasanton, CA 94588 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-22 |
| Decision Date | 2017-09-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857253006057 | K170527 | 000 |