The following data is part of a premarket notification filed by Annidis Health Systems Corp. with the FDA for Rha2020.
| Device ID | K111531 |
| 510k Number | K111531 |
| Device Name: | RHA2020 |
| Classification | Ophthalmoscope, Ac-powered |
| Applicant | ANNIDIS HEALTH SYSTEMS CORP. 2650 QUEENSVIEW DRIVE SUITE 245 Ottawa, Ontario, CA K2b 8h6 |
| Contact | Michael Mcdonnell |
| Correspondent | William Sammons INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-06-02 |
| Decision Date | 2011-07-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00627843652021 | K111531 | 000 |