K022750 is an FDA 510(k) clearance for the PLV CONTINUUM VENTILATOR, MODEL P1000. This device is classified as a Continuous, Ventilator, Home Use (Class II - Special Controls, product code NOU).
Submitted by Respironics California, Inc. (Carlsbad, US). The FDA issued a Cleared decision on November 20, 2003, 458 days after receiving the submission on August 19, 2002.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895. This Product Code Was Needed For The Home Use Indication. Cbk Is Not A Tracked Device And Nou Is A Tracked Device..
| 510(k) Number | K022750 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 19, 2002 |
| Decision Date | November 20, 2003 |
| Days to Decision | 458 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | NOU — Continuous, Ventilator, Home Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5895 |
| Definition | This Product Code Was Needed For The Home Use Indication. Cbk Is Not A Tracked Device And Nou Is A Tracked Device. |