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FDA 510(k)

Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves

K-Number: K181456 · 2019-07-08

ApplicantTuttnauer , Ltd.
Decision Date2019-07-08
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves is the device name listed in this FDA 510(k) record. The listed applicant is Tuttnauer , Ltd.. It received FDA 510(k) clearance on 2019-07-08 under 510(k) number K181456. 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 Models:4472,5596,6690,66120,69120 and 69180 autoclaves?

Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves is a medical device that received FDA 510(k) clearance on 2019-07-08. The listed applicant is Tuttnauer , Ltd.. The 510(k) number is K181456.

When did Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves receive FDA 510(k) clearance?

Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves received FDA 510(k) clearance on 2019-07-08, under 510(k) number K181456.

Who is the listed applicant for Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves?

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 Models:4472,5596,6690,66120,69120 and 69180 autoclaves?

The FDA product code for Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves 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-WSK221227Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120K213080T-Edge 10, T-Edge 11

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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