K003684 is an FDA 510(k) clearance for the PERCUSSIVENEB, MODEL PN-2001. This device is classified as a Device, Positive Pressure Breathing, Intermittent (Class II - Special Controls, product code NHJ).
Submitted by Vortran Medical Technology 1, Inc. (Sacramento, US). The FDA issued a Cleared decision on February 23, 2001, 86 days after receiving the submission on November 29, 2000.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5905.
| 510(k) Number | K003684 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 29, 2000 |
| Decision Date | February 23, 2001 |
| Days to Decision | 86 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | NHJ - Device, Positive Pressure Breathing, Intermittent |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5905 |