The following data is part of a premarket notification filed by Athelas Inc. with the FDA for Athelas Home.
| Device ID | K200828 |
| 510k Number | K200828 |
| Device Name: | Athelas Home |
| Classification | Counter, Differential Cell |
| Applicant | Athelas Inc. 67 E Evelyn Ave. Mountain View, CA 94041 |
| Contact | Tanay Tandon |
| Correspondent | Tanay Tandon Athelas Inc. 67 E Evelyn Ave. Mountain View, CA 94041 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-30 |
| Decision Date | 2022-03-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860008385864 | K200828 | 000 |
| 00860008385840 | K200828 | 000 |