FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TSO3 OZONE STERILIZER, MODEL 125L
K Number: K020875
·
Decision Aug 26, 2003
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
25
Applicant Total
2
Review Days
526
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Basic Information
- Device Name
- TSO3 OZONE STERILIZER, MODEL 125L
- K Number
- K020875
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Technologies of Sterilization With Oxone, Tso3, Inc.
- Date Received
- March 18, 2002
- Decision Date
- August 26, 2003
- Product Code
- FLF
- 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 |
|---|---|---|---|
| FLF | Sterilizer, Ethylene-Oxide Gas | FDA class 2 | General Hospital |
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TSO3 OZONE STERILIZER, MODEL 125L
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TSO3 OZONE STERILIZER, MODEL 125L
FDA 510(k)
FDA Class 2
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Other Clearances by Technologies of Sterilization With Oxone, Tso3, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K021161 | TSO3 OZONE CHEMICAL INDICATOR | Aug 27, 2003 | Substantially Equivalent |