The following data is part of a premarket notification filed by Lifecare Services, Inc. with the FDA for Lifecare Remote Alarm Ii.
| Device ID | K913423 |
| 510k Number | K913423 |
| Device Name: | LIFECARE REMOTE ALARM II |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | LIFECARE SERVICES, INC. 655 ASPEN RIDGE DR. Lafayette, CO 80026 |
| Contact | Harold R Elleringto |
| Correspondent | Harold R Elleringto LIFECARE SERVICES, INC. 655 ASPEN RIDGE DR. Lafayette, CO 80026 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-22 |
| Decision Date | 1992-01-30 |