Device Classification Name |
electrocardiograph
|
510(k) Number |
K180234 |
Device Name |
physiQ Heart Rhythm Module |
Applicant |
physiQ Inc. |
300 E. 5th Avenue, Suite 105 |
naperville,
IL
60563
|
|
Applicant Contact |
george allen hides |
Correspondent |
physiQ Inc. |
300 E. 5th Avenue, Suite 105 |
naperville,
IL
60563
|
|
Correspondent Contact |
george allen hides |
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 01/29/2018 |
Decision Date | 08/10/2018 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|