510(k) K970173 ยท BZD Ventilator, Non-Continuous (Respirator)
MODEL 1700 TRANQUILITY BILEVEL SYSTEM
| Applicant | Healthdyne Technologies, Inc., Marietta GA, US |
| Decision | Substantially Equivalent, Apr 16, 1997 |
| Received | Jan 16, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970173
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2008 | Respironics, Inc. Filters under the following brand names: a) filter std incoming 7100 CPAP qty 1 model number 1039618; b) filter reusable PLV 2/pkg model number 35220; c) LX UL Fine Filter 2 pack model number 1006193; Terminated |
BZD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.