510(k) K972614 ยท CAW Generator, Oxygen, Portable
TWISTER OXYGEN CONCENTRATOR MODEL 600, TWISTER OXYGEN CONCENTRATOR W/OPI MODEL 605
| Applicant | Healthdyne Technologies, Inc., Marietta GA, US |
| Decision | Substantially Equivalent, Jan 20, 1998 |
| Received | Jul 14, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972614
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.