510(k) K946083 ยท BYI Percussor, Powered-Electric
FLUTTER(R)
| Applicant | Bradstreet Clinical Research Assoc., Inc., Brunswick NJ, US |
| Decision | Substantially Equivalent, Mar 13, 1995 |
| Received | Dec 13, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K946083
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 22, 2015 | Aptalis Pharmatech Inc. FLUTTER Percussor respiratory device, packaged one unit per clear plastic package.
Product Usage:
Product is a percussor device, intended to be used as a mucus clearance device for patients with mu Terminated |
BYI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.