The following data is part of a premarket notification filed by Constant Care, Llc with the FDA for Constant Care Lilah Home Health Monitoring System.
Device ID | K120941 |
510k Number | K120941 |
Device Name: | CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM |
Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
Applicant | CONSTANT CARE, LLC 1300 I ST, NW, 11TH FLOOR EAST Washington, DC 20005 -3314 |
Contact | Seth A Mailhot |
Correspondent | Seth A Mailhot CONSTANT CARE, LLC 1300 I ST, NW, 11TH FLOOR EAST Washington, DC 20005 -3314 |
Product Code | DRG |
Subsequent Product Code | DQA |
Subsequent Product Code | DXN |
Subsequent Product Code | FLL |
Subsequent Product Code | FRI |
Subsequent Product Code | NBW |
Subsequent Product Code | NXQ |
CFR Regulation Number | 870.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-03-29 |
Decision Date | 2012-07-03 |
Summary: | summary |