The following data is part of a premarket notification filed by Rhythm Al, Ltd with the FDA for Star Apollo Mapping System.
| Device ID | K220786 |
| 510k Number | K220786 |
| Device Name: | STAR Apollo Mapping System |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | Rhythm Al, Ltd Office G2, Whitney Business And Innovation, Windrush House, Buford Rd Witney, GB OX 29 7DX |
| Contact | Linda D'Abate |
| Correspondent | Linda D'Abate Rhythm-Al 124 Gilbert Stuart Drive East Greenwich, RI 02818 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-17 |
| Decision Date | 2022-12-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860009793507 | K220786 | 000 |