FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING DOOR, MODELS 4472 EP-1V AND 5596 EP-1V
K Number: K032192
·
Decision Aug 12, 2004
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
183
Applicant Total
9
Review Days
392
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Basic Information
- Device Name
- PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING DOOR, MODELS 4472 EP-1V AND 5596 EP-1V
- K Number
- K032192
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 880.6880
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tuttnauer U.S.A Co, Ltd.
- Date Received
- July 17, 2003
- Decision Date
- August 12, 2004
- 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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| K990761 | TUTTNAUER MINI CONTAINER CASSETTE, TUTTNAUER STANDARD CASE CASSETTE | Jul 9, 1999 | Substantially Equivalent |
| K962282 | TUTTNAUER PREVACUUM TABLE AUTOCLAVE | Nov 12, 1997 | Substantially Equivalent |
| K973550 | TUTTNAUER TABLE-TOP AUTOCLAVE | Oct 29, 1997 | Substantially Equivalent |