FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator
K Number: K203284
·
Decision Dec 7, 2020
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
4
Applicant Total
331
Review Days
28
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Basic Information
- Device Name
- 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator
- K Number
- K203284
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.2800
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 3M Company
- Date Received
- November 9, 2020
- Decision Date
- December 7, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QKM), ordered by most recent decision date.
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FDA Class 2
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3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
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FDA Class 2
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CELERITY HP Chemical Indicator
FDA 510(k)
FDA Class 2
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3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
FDA 510(k)
FDA Class 2
·General Hospital
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| K222508 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248 | Nov 1, 2022 | Substantially Equivalent |