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FDA 510(k)

AMERICAN GOLD SERIES AUTOCLAVE

K-Number: K833837 · 1984-01-11

ApplicantTuttnauer Co. , Ltd.
Decision Date1984-01-11
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AMERICAN GOLD SERIES AUTOCLAVE is the device name listed in this FDA 510(k) record. The listed applicant is Tuttnauer Co. , Ltd.. It received FDA 510(k) clearance on 1984-01-11 under 510(k) number K833837. 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 AMERICAN GOLD SERIES AUTOCLAVE?

AMERICAN GOLD SERIES AUTOCLAVE is a medical device that received FDA 510(k) clearance on 1984-01-11. The listed applicant is Tuttnauer Co. , Ltd.. The 510(k) number is K833837.

When did AMERICAN GOLD SERIES AUTOCLAVE receive FDA 510(k) clearance?

AMERICAN GOLD SERIES AUTOCLAVE received FDA 510(k) clearance on 1984-01-11, under 510(k) number K833837.

Who is the listed applicant for AMERICAN GOLD SERIES AUTOCLAVE?

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

What is the FDA product code for AMERICAN GOLD SERIES AUTOCLAVE?

The FDA product code for AMERICAN GOLD SERIES AUTOCLAVE is FLE.

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Other records listing Tuttnauer Co. , 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.

K111736TUTTNAUER EZ PLUS SERIES ELECTRONIC TABLETOP AUTOCLAVESK063711TUTTNAUER PREVACUUM STEAM HEATED AUTOCLAVE, MODELS 6990 SP-1A, 66120 SP-1A, 69150 SP-2A, 69120 L USA SP-2A, 69180 SP-2HAK003470EHS SERIES TABLE TOP AUTOCLAVE, MODELS 2540 AND 3870K920478TUTTNAUER LSI (AUTOMATIC)K850264TUTTNAUER PRE-VACUUM AUTOCLAVE

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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