The following data is part of a premarket notification filed by Lifecare Services, Inc. with the FDA for Portable Lifecare Ventilator Plv-102.
| Device ID | K842876 |
| 510k Number | K842876 |
| Device Name: | PORTABLE LIFECARE VENTILATOR PLV-102 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | LIFECARE SERVICES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-23 |
| Decision Date | 1984-08-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00606959020276 | K842876 | 000 |
| 00606959020269 | K842876 | 000 |
| 00606959043220 | K842876 | 000 |
| 00606959043206 | K842876 | 000 |
| 00606959043008 | K842876 | 000 |