AMERICAN GOLD SERIES AUTOCLAVE— 510(k) K833837
Substantially EquivalentTuttnauer Co. , Ltd.
FDA 510(k) clearance K833837 for AMERICAN GOLD SERIES AUTOCLAVE, Substantially Equivalent on 1984-01-11. Applicant: Tuttnauer Co. , Ltd.. Device class: 2.
Clearance details
- Applicant
- Tuttnauer 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
- Walker, MI, US
Recent devices under product code FLE
view allMore clearances from Tuttnauer Co. , Ltd.
view all- K111736 — TUTTNAUER EZ PLUS SERIES ELECTRONIC TABLETOP AUTOCLAVES
- K063711 — TUTTNAUER PREVACUUM STEAM HEATED AUTOCLAVE, MODELS 6990 SP-1A, 66120 SP-1A, 69150 SP-2A, 69120 L USA SP-2A, 69180 SP-2HA
- K003470 — EHS SERIES TABLE TOP AUTOCLAVE, MODELS 2540 AND 3870
- K920478 — TUTTNAUER LSI (AUTOMATIC)
- K850264 — TUTTNAUER PRE-VACUUM AUTOCLAVE
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.