FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
K Number: K193110
·
Decision Mar 13, 2020
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
4
Applicant Total
21
Review Days
122
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Basic Information
- Device Name
- 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
- K Number
- K193110
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2800
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 3M Healthcare
- Date Received
- November 12, 2019
- Decision Date
- March 13, 2020
- Product Code
- QKM
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QKM | A Chemical Vapor Sterilization Multivariable Chemical Indicator | FDA class 2 | General Hospital |
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