The following data is part of a premarket notification filed by Blue Focus with the FDA for Aio Hd Otoscope.
| Device ID | K123821 |
| 510k Number | K123821 |
| Device Name: | AIO HD OTOSCOPE |
| Classification | Otoscope |
| Applicant | BLUE FOCUS 965 OAKLAND RD SUITE 2B Lawrenceville, GA 30044 |
| Contact | Ki Cheol Han |
| Correspondent | Ki Cheol Han BLUE FOCUS 965 OAKLAND RD SUITE 2B Lawrenceville, GA 30044 |
| Product Code | ERA |
| CFR Regulation Number | 874.4770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-12 |
| Decision Date | 2013-05-17 |
| Summary: | summary |