510(k) K121631 ยท BZD Ventilator, Non-Continuous (Respirator)
SIMPLE T NASAL MASK
| Applicant | Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, Oct 5, 2012 |
| Received | Jun 4, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K121631
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2022 | Philips Respironics, Inc. Wisp and Wisp Youth Nasal Mask Open, Classified |
BZD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.