510(k) K953363 ยท BZQ Monitor, Breathing Frequency
OXIFLOW DIGITAL RECORDER
| Applicant | Edentec Corp., Eden Prairie MN, US |
| Decision | Substantially Equivalent - Subject to Tracking Reg., Feb 6, 1996 |
| Received | Jul 17, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953363
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.