FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SES-2012 AUTOMATIC STEAM STERILIZER
K Number: K924596
·
Decision Apr 15, 1994
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
183
Applicant Total
6
Review Days
581
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Basic Information
- Device Name
- SES-2012 AUTOMATIC STEAM STERILIZER
- K Number
- K924596
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6880
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Porter Instrument Co., Inc.
- Date Received
- September 11, 1992
- Decision Date
- April 15, 1994
- Product Code
- FLE
- 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 |
|---|---|---|---|
| FLE | Sterilizer, Steam | FDA class 2 | General Hospital |
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Other Clearances by Porter Instrument Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K062155 | DIGITAL MXR-D FLOWMETER | Nov 9, 2006 | Substantially Equivalent |
| K981754 | AUTOMATIC VACUUM SWITCH (AVS) MODEL NUMBER AVS 5000 | Jun 16, 1998 | Substantially Equivalent |
| K923781 | MXR-2000 FLOWMETER | Jun 10, 1993 | Substantially Equivalent |
| K895638 | STEAM STERILIZER (AUTOCLAVE), DENTAL | Feb 22, 1990 | Substantially Equivalent |
| K802067 | CLEAN-AIR POLLUTION REDUCTION SYSTEM | Sep 26, 1980 | Substantially Equivalent |