The following data is part of a premarket notification filed by American Diagnostic Corp. with the FDA for Otoscope And Ophthalmoscope Diagnostic Instrument Kits.
| Device ID | K093495 |
| 510k Number | K093495 |
| Device Name: | OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS |
| Classification | Ophthalmoscope, Battery-powered |
| Applicant | AMERICAN DIAGNOSTIC CORP. 55 COMMERCE DR. Hauppauge, NY 11788 |
| Contact | Michael Falco |
| Correspondent | Michael Falco AMERICAN DIAGNOSTIC CORP. 55 COMMERCE DR. Hauppauge, NY 11788 |
| Product Code | HLJ |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-10 |
| Decision Date | 2010-11-19 |