The following data is part of a premarket notification filed by Amico Diagnostic Incorporated with the FDA for Amico Dh-w35 Ophthalmoscope Series.
| Device ID | K131939 |
| 510k Number | K131939 |
| Device Name: | AMICO DH-W35 OPHTHALMOSCOPE SERIES |
| Classification | Ophthalmoscope, Ac-powered |
| Applicant | AMICO DIAGNOSTIC INCORPORATED 445 APOLLO BEACH BLVD. Apollo Beach, FL 33572 |
| Contact | Lauren Chrapowitzky |
| Correspondent | Lauren Chrapowitzky AMICO DIAGNOSTIC INCORPORATED 445 APOLLO BEACH BLVD. Apollo Beach, FL 33572 |
| Product Code | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-27 |
| Decision Date | 2014-03-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00697077002329 | K131939 | 000 |
| 00697077001063 | K131939 | 000 |
| 00697077000028 | K131939 | 000 |