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FDA 510(k)

BELIMED STEAM STERILIZER, MODEL TOP 5000

K-Number: K021223 · 2002-06-26

ApplicantSauter AG
Decision Date2002-06-26
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BELIMED STEAM STERILIZER, MODEL TOP 5000 is the device name listed in this FDA 510(k) record. The listed applicant is Sauter AG. It received FDA 510(k) clearance on 2002-06-26 under 510(k) number K021223. 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 BELIMED STEAM STERILIZER, MODEL TOP 5000?

BELIMED STEAM STERILIZER, MODEL TOP 5000 is a medical device that received FDA 510(k) clearance on 2002-06-26. The listed applicant is Sauter AG. The 510(k) number is K021223.

When did BELIMED STEAM STERILIZER, MODEL TOP 5000 receive FDA 510(k) clearance?

BELIMED STEAM STERILIZER, MODEL TOP 5000 received FDA 510(k) clearance on 2002-06-26, under 510(k) number K021223.

Who is the listed applicant for BELIMED STEAM STERILIZER, MODEL TOP 5000?

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

What is the FDA product code for BELIMED STEAM STERILIZER, MODEL TOP 5000?

The FDA product code for BELIMED STEAM STERILIZER, MODEL TOP 5000 is FLE.

Related Clinical Trials

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.

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Other records listing Sauter AG 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.

K103841BELIMED STEAM STERILIZER MST-VK060337BELIMED STEAM STERILIZER TOP 5000, MODEL 5-5-9K033538BELIMED STEAM STERILIZER TOP 5000, SERIES 4 - 8

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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