Pre-vacuum Tabletop Autoclave— 510(k) K143311
Substantially EquivalentTuttnauer U.S.A Co, Ltd.
FDA 510(k) clearance K143311 for Pre-vacuum Tabletop Autoclave, Substantially Equivalent on 2015-01-15. Applicant: Tuttnauer U.S.A Co, Ltd.. Device class: 2.
Clearance details
- Applicant
- Tuttnauer U.S.A Co, Ltd.
- Product code
- Code FLE
- Device class
- Class 2
- Regulation
- 21 CFR 880.6880
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hauppauge, NY, US
Recent devices under product code FLE
view allMore clearances from Tuttnauer U.S.A Co, Ltd.
view all- K232658 — T-Top 10 & T-Top T-Top 11
- K090783 — TUTTNAUER ELARA-11 PRE-VACUUM TABLETOP AUTOCLAVE
- K032192 — PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING DOOR, MODELS 4472 EP-1V AND 5596 EP-1V
- K021504 — TUTTNAUER EHS SERIES TABLE-TOP AUTOCLAVE, MODEL 2540
- K993856 — TUTTNAUER ELECTRONIC AUTOCLAVE, MODELS E, EA, EK, EKA, EP
Adverse events under product code FLE
product code FLE- Malfunction
- 444
- Total
- 444
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.