FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HARVEY PV DRY STERILIZER, MODEL # ST127325; ST127320; ST127320-33
K Number: K014174
·
Decision Feb 22, 2002
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
183
Applicant Total
2
Review Days
64
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Basic Information
- Device Name
- HARVEY PV DRY STERILIZER, MODEL # ST127325; ST127320; ST127320-33
- K Number
- K014174
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6880
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Barnstead/Thermolyne Corp.
- Date Received
- December 20, 2001
- Decision Date
- February 22, 2002
- Product Code
- FLE
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FLE | Sterilizer, Steam | FDA class 2 | General Hospital |
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Other Clearances by Barnstead/Thermolyne Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K953938 | STERILEMAX | Jan 30, 1997 | Substantially Equivalent |