K982889 is an FDA 510(k) clearance for the MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000. This device is classified as a Percussor, Powered-electric (Class II - Special Controls, product code BYI).
Submitted by Electromed, Inc. (Minnetonka, US). The FDA issued a Cleared decision on June 1, 1999, 288 days after receiving the submission on August 17, 1998.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5665.
| 510(k) Number | K982889 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 17, 1998 |
| Decision Date | June 01, 1999 |
| Days to Decision | 288 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BYI - Percussor, Powered-electric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5665 |