The following data is part of a premarket notification filed by Lifecare Services, Inc. with the FDA for Lifecare Cpap-100.
| Device ID | K912224 |
| 510k Number | K912224 |
| Device Name: | LIFECARE CPAP-100 |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | LIFECARE SERVICES, INC. 655 ASPEN RIDGE DR. Lafayette, CO 80026 |
| Contact | Harold R.ellerington |
| Correspondent | Harold R.ellerington LIFECARE SERVICES, INC. 655 ASPEN RIDGE DR. Lafayette, CO 80026 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-20 |
| Decision Date | 1991-09-23 |