FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GETINGE 400HC-E / SERIES STEAM STERILIZER
K Number: K122071
·
Decision Mar 12, 2013
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
183
Applicant Total
7
Review Days
239
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Basic Information
- Device Name
- GETINGE 400HC-E / SERIES STEAM STERILIZER
- K Number
- K122071
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6880
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Getinge Sourcing, LLC
- Date Received
- July 16, 2012
- Decision Date
- March 12, 2013
- 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 Getinge Sourcing, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K153713 | Getinge Series Warming Cabinet | Jun 7, 2016 | Substantially Equivalent |
| K122625 | GETINGE 800HC- SERIES STEAM STERILIZER | May 22, 2013 | Substantially Equivalent |
| K120532 | GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM | May 2, 2013 | Substantially Equivalent |
| K120441 | GETINGE 700HC-E SERIES STEAM STERILIZER | May 31, 2012 | Substantially Equivalent |
| K103504 | GETINGE 400HC/500HC SERIES STEAM STERILIZER | Mar 16, 2011 | Substantially Equivalent |
| K070657 | GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER | Apr 5, 2007 | Substantially Equivalent |