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FDA 510(k)

Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120

K-Number: K221227 · 2022-09-20

ApplicantTuttnauer , Ltd.
Decision Date2022-09-20
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120 is the device name listed in this FDA 510(k) record. The listed applicant is Tuttnauer , Ltd.. It received FDA 510(k) clearance on 2022-09-20 under 510(k) number K221227. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120?

Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120 is a medical device that received FDA 510(k) clearance on 2022-09-20. The listed applicant is Tuttnauer , Ltd.. The 510(k) number is K221227.

When did Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120 receive FDA 510(k) clearance?

Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120 received FDA 510(k) clearance on 2022-09-20, under 510(k) number K221227.

Who is the listed applicant for Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120?

The FDA 510(k) record lists Tuttnauer , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120?

The FDA product code for Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120 is FLE.

Other records listing Tuttnauer , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K222608Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WSK213080T-Edge 10, T-Edge 11K181456Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves

Related Devices (Code: FLE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261055AMSCO 700 Steam SterilizerSTERIS CorporationK260254Enbio PROEnbio Group AGK252307Getinge GSS67N Series Steam SterilizerMaquet GmbH (A Getinge Group Company)K250168Life Ultra 25L Tabletop Mono Chamber Steam SterilizerLucas LifecareK250164Cassette Autoclave (ACA5)Guangzhou Ajax Medical Equipment Co., Ltd.K243994Steam Sterilizer (2545D)Ningbo Ican Machines Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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