K034032 is an FDA 510(k) clearance for the PLV CONTINUUM VENTILATOR, MODEL P2000. 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 March 16, 2004, 78 days after receiving the submission on December 29, 2003.
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 | K034032 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 2003 |
| Decision Date | March 16, 2004 |
| Days to Decision | 78 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. |