The following data is part of a premarket notification filed by Lifecare Services, Inc. with the FDA for Nev-10 Negative Pressure Ventilator.
| Device ID | K910947 |
| 510k Number | K910947 |
| Device Name: | NEV-10 NEGATIVE PRESSURE VENTILATOR |
| Classification | Ventilator, External Body, Negative Pressure, Adult (cuirass) |
| Applicant | LIFECARE SERVICES, INC. 655 ASPEN RIDGE DR. Lafayette, CO 80026 |
| Contact | Harold Ellerington |
| Correspondent | Harold Ellerington LIFECARE SERVICES, INC. 655 ASPEN RIDGE DR. Lafayette, CO 80026 |
| Product Code | BYT |
| CFR Regulation Number | 868.5935 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-06 |
| Decision Date | 1991-06-03 |