TUTTNAUER ELECTRONIC AUTOCLAVE, MODELS E, EA, EK, EKA, EP— 510(k) K993856
Substantially EquivalentTuttnauer U.S.A Co, Ltd.
FDA 510(k) clearance K993856 for TUTTNAUER ELECTRONIC AUTOCLAVE, MODELS E, EA, EK, EKA, EP, Substantially Equivalent on 2001-02-09. 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
- Washington, DC, 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
- K143311 — Pre-vacuum Tabletop Autoclave
- 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
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.