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FDA 510(k)

Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS

K-Number: K222608 · 2022-12-16

ApplicantTuttnauer , Ltd.
Decision Date2022-12-16
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS is the device name listed in this FDA 510(k) record. The listed applicant is Tuttnauer , Ltd.. It received FDA 510(k) clearance on 2022-12-16 under 510(k) number K222608. 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 Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS?

Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS is a medical device that received FDA 510(k) clearance on 2022-12-16. The listed applicant is Tuttnauer , Ltd.. The 510(k) number is K222608.

When did Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS receive FDA 510(k) clearance?

Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS received FDA 510(k) clearance on 2022-12-16, under 510(k) number K222608.

Who is the listed applicant for Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS?

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 Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS?

The FDA product code for Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS 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.

K221227Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120K213080T-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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