510(k) K212201 ยท PCV Endoscopic Leak Tester
PENTAX Medical Auto Leakage Tester SHA-P6
| Applicant | Pentax of America, Inc., Montvale NJ, US |
| Decision | Substantially Equivalent, Oct 1, 2021 |
| Received | Jul 14, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212201
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.