Device Classification Name |
oximeter
|
510(k) Number |
K212153 |
Device Name |
Biobeat Platform, BB-613WP Patch |
Applicant |
BioBeat Technologies Ltd. |
26 Ha'magshimim Street |
Petah Tikvah,
IL
4934835
|
|
Applicant Contact |
Johanan May |
Correspondent |
Hogan Lovells US LLP |
555 Thirteenth St., NW |
Washington,
DC
20004
|
|
Correspondent Contact |
John J. Smith |
Regulation Number | 870.2700
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/09/2021 |
Decision Date | 03/25/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|