The following data is part of a premarket notification filed by Lifecare Services, Inc. with the FDA for Lifecare Remote Alarm #34-001.
| Device ID | K862212 |
| 510k Number | K862212 |
| Device Name: | LIFECARE REMOTE ALARM #34-001 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | LIFECARE SERVICES, INC. 5505 CENTRAL AVE. Boulder, CO 80301 |
| Contact | Marc Bergman |
| Correspondent | Marc Bergman LIFECARE SERVICES, INC. 5505 CENTRAL AVE. Boulder, CO 80301 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-10 |
| Decision Date | 1986-06-23 |