The following data is part of a premarket notification filed by Coala Life Ab with the FDA for Coala Heart Monitor.
| Device ID | K212163 |
| 510k Number | K212163 |
| Device Name: | Coala Heart Monitor |
| Classification | Electrocardiograph |
| Applicant | Coala Life AB Kalsangsgrand 10B Uppsala, SE 75319 |
| Contact | Dan Pitulia |
| Correspondent | Pierre Bounaud AcKnowledge Regulatory Strategies 2251 San Diego Ave, Suite B-257 San Diego, CA 92110 |
| Product Code | DPS |
| Subsequent Product Code | DQC |
| Subsequent Product Code | DQD |
| Subsequent Product Code | DXH |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-12 |
| Decision Date | 2022-04-14 |