510(k) K003704 ยท BZQ Monitor, Breathing Frequency
OPTOVENT RESPONS, OPTOVENT RENEE (OPTOVENT RESPONS WITHOUT PULSE OXIMETRY MODULE)
| Applicant | Optovent AB, Fort Lee NJ, US |
| Decision | Substantially Equivalent, Feb 5, 2001 |
| Received | Dec 1, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003704
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.