The following data is part of a premarket notification filed by Lifecare Services, Inc. with the FDA for Portable Lifecare Ventilator Plv-100.
| Device ID | K832467 |
| 510k Number | K832467 |
| Device Name: | PORTABLE LIFECARE VENTILATOR PLV-100 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | LIFECARE SERVICES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-02 |
| Decision Date | 1983-10-20 |