510(k) K132439 ยท FLE Sterilizer, Steam
SAKURA STEAM STERILIZER ASSR; -AO12, -A012W, -AO12P,-AO12PW / SKYTRON INTEGRITY 270;STEAM STERILIZER,VP STEAM STERILIZER
| Applicant | Sakura Seiki Co., Ltd., Great Neck NY, US |
| Decision | Substantially Equivalent, Jan 6, 2014 |
| Received | Aug 5, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132439
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 18, 2019 | Skytron, Div. The KMW Group, Inc Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam
Product Usage:
The SKYTRON Integrity 270 Steam Sterilizer for use in health care facilities. The Integrity Sterilizer incorpor Terminated |
FLE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.