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FDA 510(k)

STATIM 6000B Vacuum Autoclave

K-Number: K214057 · 2022-03-31

ApplicantScican , Ltd.
Decision Date2022-03-31
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STATIM 6000B Vacuum Autoclave is the device name listed in this FDA 510(k) record. The listed applicant is Scican , Ltd.. It received FDA 510(k) clearance on 2022-03-31 under 510(k) number K214057. 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 STATIM 6000B Vacuum Autoclave?

STATIM 6000B Vacuum Autoclave is a medical device that received FDA 510(k) clearance on 2022-03-31. The listed applicant is Scican , Ltd.. The 510(k) number is K214057.

When did STATIM 6000B Vacuum Autoclave receive FDA 510(k) clearance?

STATIM 6000B Vacuum Autoclave received FDA 510(k) clearance on 2022-03-31, under 510(k) number K214057.

Who is the listed applicant for STATIM 6000B Vacuum Autoclave?

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

What is the FDA product code for STATIM 6000B Vacuum Autoclave?

The FDA product code for STATIM 6000B Vacuum Autoclave is FLE.

Other records listing Scican , 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.

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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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