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 - Multi-user Version.
| Device ID | K130360 |
| 510k Number | K130360 |
| Device Name: | CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM - MULTI-USER VERSION |
| 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 | BZH |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| Subsequent Product Code | FRI |
| Subsequent Product Code | INF |
| 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 | 2013-02-13 |
| Decision Date | 2013-07-15 |
| Summary: | summary |