Data / Medical devices / Hungary / Tuttnauer Kft.
Tuttnauer Kft.: FDA-registered device maker in Dunakeszi Pest, Hungary, 13 510(k) clearances
Tuttnauer Kft. is registered with the FDA (registration 3027434168) in Dunakeszi Pest, Hungary. It lists 1 device type. The FDA files 13 510(k) clearances under its listings, the newest dated November 27, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027434168
- Address
- 43 Pallag Utca, Dunakeszi Pest, Hungary, 2120
- Owner or operator
- TUTTNAUER LTD. (8030087)
- Roles
- Manufacturer
- First device listed
- December 7, 2007
- Registered through
- 2026
- Brand names listed
- 1730, 2340, 2540, 3870 - E, 1730, 2340, 2540, 3870 E/EK/EP, EZ9, EZ10, 3870 E/M, 2340, 2540, 3870 EA/EKA, 3870HSG and 3870HSG-WS, 4472, 5596, 6690, 66120, 69150, 6990, 69120, 69180, ELARA11, ELARAII, EZ9, EZ11, EZ15 - PLUS and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Sterilizer, Steam | FLE | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 27, 2023 | K232658 | T-Top 10 & T-Top T-Top 11 | FLE | Substantially Equivalent | Tuttnauer U.S.A Co, Ltd. | accessdata.fda.gov |
| December 16, 2022 | K222608 | Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS | FLE | Substantially Equivalent | Tuttnauer , Ltd. | accessdata.fda.gov |
| January 4, 2022 | K213080 | T-Edge 10, T-Edge 11 | FLE | Substantially Equivalent | Tuttnauer , Ltd. | accessdata.fda.gov |
| July 8, 2019 | K181456 | Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves | FLE | Substantially Equivalent | Tuttnauer , Ltd. | accessdata.fda.gov |
| January 15, 2015 | K143311 | Pre-vacuum Tabletop Autoclave | FLE | Substantially Equivalent | Tuttnauer U.S.A Co, Ltd. | accessdata.fda.gov |
| December 8, 2011 | K111736 | TUTTNAUER EZ PLUS SERIES ELECTRONIC TABLETOP AUTOCLAVES | FLE | Substantially Equivalent | Tuttnauer Co. , Ltd. | accessdata.fda.gov |
| August 20, 2009 | K090783 | TUTTNAUER ELARA-11 PRE-VACUUM TABLETOP AUTOCLAVE | FLE | Substantially Equivalent | Tuttnauer U.S.A Co, Ltd. | accessdata.fda.gov |
| February 2, 2007 | K063711 | TUTTNAUER PREVACUUM STEAM HEATED AUTOCLAVE, MODELS 6990 SP-1A, 66120 SP-1A, 69150 SP-2A, 69120 L USA SP-2A, 69180 SP-2HA | FLE | Substantially Equivalent | Tuttnauer Co. , Ltd. | accessdata.fda.gov |
| August 12, 2004 | K032192 | PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING DOOR, MODELS 4472 EP-1V AND 5596 EP-1V | FLE | Substantially Equivalent | Tuttnauer U.S.A Co, Ltd. | accessdata.fda.gov |
| February 9, 2001 | K993856 | TUTTNAUER ELECTRONIC AUTOCLAVE, MODELS E, EA, EK, EKA, EP | FLE | Substantially Equivalent | Tuttnauer U.S.A Co, Ltd. | accessdata.fda.gov |
| October 29, 1997 | K973550 | TUTTNAUER TABLE-TOP AUTOCLAVE | FLE | Substantially Equivalent | Tuttnauer U.S.A Co, Ltd. | accessdata.fda.gov |
| July 8, 1993 | K920478 | TUTTNAUER LSI (AUTOMATIC) | FLE | Substantially Equivalent | Tuttnauer Co. , Ltd. | accessdata.fda.gov |
| January 11, 1984 | K833837 | AMERICAN GOLD SERIES AUTOCLAVE | FLE | Substantially Equivalent | Tuttnauer Co. , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated November 27, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.