FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TUTTNAUER EHS SERIES TABLE-TOP AUTOCLAVE, MODEL 2540
K Number: K021504
·
Decision Jul 25, 2002
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
183
Applicant Total
9
Review Days
77
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Basic Information
- Device Name
- TUTTNAUER EHS SERIES TABLE-TOP AUTOCLAVE, MODEL 2540
- K Number
- K021504
- 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
- May 9, 2002
- Decision Date
- July 25, 2002
- 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 U.S.A Co, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K232658 | T-Top 10 & T-Top T-Top 11 | Nov 27, 2023 | Substantially Equivalent |
| K143311 | Pre-vacuum Tabletop Autoclave | Jan 15, 2015 | Substantially Equivalent |
| K090783 | TUTTNAUER ELARA-11 PRE-VACUUM TABLETOP AUTOCLAVE | Aug 20, 2009 | Substantially Equivalent |
| K032192 | PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING DOOR, MODELS 4472 EP-1V AND 5596 EP-1V | Aug 12, 2004 | Substantially Equivalent |
| K993856 | TUTTNAUER ELECTRONIC AUTOCLAVE, MODELS E, EA, EK, EKA, EP | Feb 9, 2001 | Substantially Equivalent |
| 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 |