K021981 is an FDA 510(k) clearance for the IVENT 201 PORTABLE VENTILATOR. This device is classified as a Continuous, Ventilator, Home Use (Class II - Special Controls, product code NOU).
Submitted by Versamed , Ltd. (Kadima, IL). The FDA issued a Cleared decision on August 13, 2003, 422 days after receiving the submission on June 17, 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 | K021981 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 17, 2002 |
| Decision Date | August 13, 2003 |
| Days to Decision | 422 days |
| Submission Type | Abbreviated |
| 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. |