Device Classification Name |
transmitters and receivers, physiological signal, radiofrequency
|
510(k) Number |
K211822 |
Device Name |
LifePath Remote Patient Monitoring Platform |
Applicant |
Elastic Care Incorporated |
95 Apple Creek Blvd. |
Markham,
CA
L3R 1C7
|
|
Applicant Contact |
Ashok Kalle |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Prithul Bom |
Regulation Number | 870.2910
|
Classification Product Code |
|
Date Received | 06/14/2021 |
Decision Date | 02/03/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|