FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
V-PRO maX 2 Low Temperature Sterilization System
K Number: K223476
·
Decision Aug 7, 2023
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
46
Applicant Total
204
Review Days
262
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Basic Information
- Device Name
- V-PRO maX 2 Low Temperature Sterilization System
- K Number
- K223476
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- STERIS Corporation
- Date Received
- November 18, 2022
- Decision Date
- August 7, 2023
- Product Code
- MLR
- 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 |
|---|---|---|---|
| MLR | Sterilizer, Chemical | FDA class 2 | General Hospital |
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