510(k) K970046 ยท KHA Mask, Scavenging
UNIVERSAL LOW PROFILE NASAL HOODS(1250,1275,1350,1450,1475,1550)
| Applicant | Accutron, Inc., Phoenix AZ, US |
| Decision | Substantially Equivalent, Mar 28, 1997 |
| Received | Jan 6, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970046
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.