FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
STERIZONE VP4 Sterilizer
K Number: K173694
·
Decision Mar 13, 2018
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
5
Applicant Total
10
Review Days
102
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Basic Information
- Device Name
- STERIZONE VP4 Sterilizer
- K Number
- K173694
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tso3, Inc.
- Date Received
- December 1, 2017
- Decision Date
- March 13, 2018
- Product Code
- PJJ
- 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 |
|---|---|---|---|
| PJJ | Two Or More Sterilant Sterilizer | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PJJ), ordered by most recent decision date.
STERIZONE(R) VP4 Sterilizer
FDA 510(k)
FDA Class 2
·General Hospital
STERIZONE VP4 Sterilizer
FDA 510(k)
FDA Class 2
·General Hospital
STERIZONE Sterilizer
FDA 510(k)
FDA Class 2
·General Hospital
STERIZONE VP4 Sterilizer
FDA 510(k)
FDA Class 2
·General Hospital
STERIZONE STERILIZER
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Tso3, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K190260 | STERIZONE(R) VP4 Sterilizer | Jul 19, 2019 | Substantially Equivalent |
| K172191 | STERIZONE VP4 Sterilizer | May 9, 2018 | Substantially Equivalent |
| K153689 | STERIZONE Sterilizer | Jun 30, 2016 | Substantially Equivalent |
| K141698 | STERIZONE CHEMICAL INDICATOR | Dec 17, 2014 | Substantially Equivalent |
| K141580 | STERIZONE SELF-CONTAINED BIOLOGICAL INDICATOR | Dec 17, 2014 | Substantially Equivalent |
| K141163 | STERIZONE STERILIZER | Dec 17, 2014 | Substantially Equivalent |
| K090636 | TSO3 OZONE STERILIZER, MODEL 125L | Dec 2, 2009 | Substantially Equivalent |
| K080198 | TSO3 OZONE STERILIZATION WRAP | May 30, 2008 | Substantially Equivalent |
| K051595 | TSO3 OZONE STERILIZER, MODEL 125L | Jul 26, 2006 | Substantially Equivalent |