Device Classification Name |
plethysmograph, impedance
|
510(k) Number |
K211585 |
Device Name |
Bodyport Cardiac Scale |
Applicant |
Bodyport Inc. |
970 Folsom Street |
San Francisco,
CA
94107
|
|
Applicant Contact |
Mara Korsunsky |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Prithul Bom |
Regulation Number | 870.2770
|
Classification Product Code |
|
Date Received | 05/24/2021 |
Decision Date | 07/29/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|