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FDA 510(k)

ELECTRICALLY HEATED STERILIZER STEAM STERILIZER

K-Number: K844649 · 1985-08-05

ApplicantTakizawa Medical Instruments Manufacturer
Decision Date1985-08-05
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ELECTRICALLY HEATED STERILIZER STEAM STERILIZER is the device name listed in this FDA 510(k) record. The listed applicant is Takizawa Medical Instruments Manufacturer. It received FDA 510(k) clearance on 1985-08-05 under 510(k) number K844649. 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 ELECTRICALLY HEATED STERILIZER STEAM STERILIZER?

ELECTRICALLY HEATED STERILIZER STEAM STERILIZER is a medical device that received FDA 510(k) clearance on 1985-08-05. The listed applicant is Takizawa Medical Instruments Manufacturer. The 510(k) number is K844649.

When did ELECTRICALLY HEATED STERILIZER STEAM STERILIZER receive FDA 510(k) clearance?

ELECTRICALLY HEATED STERILIZER STEAM STERILIZER received FDA 510(k) clearance on 1985-08-05, under 510(k) number K844649.

Who is the listed applicant for ELECTRICALLY HEATED STERILIZER STEAM STERILIZER?

The FDA 510(k) record lists Takizawa Medical Instruments Manufacturer as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELECTRICALLY HEATED STERILIZER STEAM STERILIZER?

The FDA product code for ELECTRICALLY HEATED STERILIZER STEAM STERILIZER is FLE.

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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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