3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
FDA 510(k) clearance K193110 · decided 2020-03-13
Clearance details
- K-number
- K193110
- Device name
- 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
- Applicant
- 3M Healthcare
- Decision
- Substantially Equivalent
- Date received
- 2019-11-12
- Decision date
- 2020-03-13
- Days to decision
- 122 days
- Clearance type
- Traditional
- Product code
- QKM
- Device class
- 2
- Regulation number
- 880.2800
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- St. Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| a. Comply INDICATOR, COMPLY VAPOR GAS (250/BG 4BG/CS) 3M Model Number: 1248. b. 3M Attest recall (Z-1794-2022) | Mckesson Medical-Surgical Inc. Corporate Office | 2022-09-26 |