The following data is part of a premarket notification filed by Coala Life Ab with the FDA for Coala Heart Monitor.
| Device ID | K182040 |
| 510k Number | K182040 |
| Device Name: | Coala Heart Monitor |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | Coala Life AB Riddargatan 18 Stockholm, SE 114 51 |
| Contact | Philip Siberg |
| Correspondent | Pierre Bounaud Acknowledge Regulatory Strategies 2251 San Diego Ave, Suite B-257 San Diego, CA 92110 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-30 |
| Decision Date | 2019-02-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 27350002700123 | K182040 | 000 |