FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SteroScope® Sterilization Technology System
K Number: K233762
·
Decision Jun 27, 2024
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
46
Applicant Total
1
Review Days
216
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Basic Information
- Device Name
- SteroScope® Sterilization Technology System
- K Number
- K233762
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ideate Medical, Inc.
- Date Received
- November 24, 2023
- Decision Date
- June 27, 2024
- 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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