510(k) K002768 ยท BWF Spirometer, Therapeutic (Incentive)
ACAPELLA
| Applicant | Dhd Healthcare Corp., Wampsville NY, US |
| Decision | Substantially Equivalent, Dec 5, 2000 |
| Received | Sep 6, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002768
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 21, 2020 | Smiths Medical ASD Inc. Portex Acapella DH Vibratory PEP Device - Product Usage: a single patient use device that provides Positive Expiratory Pressure (PEP) Therapy for patients who have Cystic Fibrosis, COPD, asthma, and l Terminated |
BWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.