510(k) K193110 ยท QKM A Chemical Vapor Sterilization Multivariable Chemical Indicator
3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
| Applicant | 3M Healthcare, St. Paul MN, US |
| Decision | Substantially Equivalent, Mar 13, 2020 |
| Received | Nov 12, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193110
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office a. Comply INDICATOR, COMPLY VAPOR GAS (250/BG 4BG/CS) 3M Model Number: 1248.
b. 3M Attest INDICATOR, CHEMICAL VAPORIZEDHYDROGEN PEROXIDE (250/BG) Model Number: 1348. Open, Classified |
JOJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.