The following data is part of a premarket notification filed by Elastic Care Incorporated with the FDA for Lifepath Remote Patient Monitoring Platform.
Device ID | K211822 |
510k Number | K211822 |
Device Name: | LifePath Remote Patient Monitoring Platform |
Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
Applicant | Elastic Care Incorporated 95 Apple Creek Blvd. Markham, CA L3r 1c7 |
Contact | Ashok Kalle |
Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
Product Code | DRG |
CFR Regulation Number | 870.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2021-06-14 |
Decision Date | 2022-02-03 |