510(k) K250164 ยท FLE Sterilizer, Steam
Cassette Autoclave (ACA5)
| Applicant | Guangzhou Ajax Medical Equipment Co., Ltd., Guangzhou, CN |
| Decision | Substantially Equivalent, Aug 14, 2025 |
| Received | Jan 21, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250164
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.