Device Classification Name |
transmitters and receivers, electrocardiograph, telephone
|
510(k) Number |
K182040 |
Device Name |
Coala Heart Monitor |
Applicant |
Coala Life AB |
Riddargatan 18 |
Stockholm,
SE
114 51
|
|
Applicant Contact |
Philip Siberg |
Correspondent |
Acknowledge Regulatory Strategies |
2251 San Diego Ave, Suite B-257 |
San Diego,
CA
92110
|
|
Correspondent Contact |
Pierre Bounaud |
Regulation Number | 870.2920
|
Classification Product Code |
|
Date Received | 07/30/2018 |
Decision Date | 02/08/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|