FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TUTTNAUER EZ PLUS SERIES ELECTRONIC TABLETOP AUTOCLAVES
K Number: K111736
·
Decision Dec 8, 2011
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
183
Applicant Total
6
Review Days
171
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Basic Information
- Device Name
- TUTTNAUER EZ PLUS SERIES ELECTRONIC TABLETOP AUTOCLAVES
- K Number
- K111736
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6880
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tuttnauer Co. , Ltd.
- Date Received
- June 20, 2011
- Decision Date
- December 8, 2011
- 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 Tuttnauer Co. , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K063711 | TUTTNAUER PREVACUUM STEAM HEATED AUTOCLAVE, MODELS 6990 SP-1A, 66120 SP-1A, 69150 SP-2A, 69120 L USA SP-2A, 69180 SP-2HA | Feb 2, 2007 | Substantially Equivalent |
| K003470 | EHS SERIES TABLE TOP AUTOCLAVE, MODELS 2540 AND 3870 | Feb 20, 2001 | Substantially Equivalent |
| K920478 | TUTTNAUER LSI (AUTOMATIC) | Jul 8, 1993 | Substantially Equivalent |
| K850264 | TUTTNAUER PRE-VACUUM AUTOCLAVE | Jun 4, 1985 | Substantially Equivalent |
| K833837 | AMERICAN GOLD SERIES AUTOCLAVE | Jan 11, 1984 | Substantially Equivalent |