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FDA 510(k)

STEAM STERILIZATION EQUIPMENT

K-Number: K821591 · 1982-06-22

ApplicantGetinge International, Inc.
Decision Date1982-06-22
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STEAM STERILIZATION EQUIPMENT is the device name listed in this FDA 510(k) record. The listed applicant is Getinge International, Inc.. It received FDA 510(k) clearance on 1982-06-22 under 510(k) number K821591. 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 STEAM STERILIZATION EQUIPMENT?

STEAM STERILIZATION EQUIPMENT is a medical device that received FDA 510(k) clearance on 1982-06-22. The listed applicant is Getinge International, Inc.. The 510(k) number is K821591.

When did STEAM STERILIZATION EQUIPMENT receive FDA 510(k) clearance?

STEAM STERILIZATION EQUIPMENT received FDA 510(k) clearance on 1982-06-22, under 510(k) number K821591.

Who is the listed applicant for STEAM STERILIZATION EQUIPMENT?

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

What is the FDA product code for STEAM STERILIZATION EQUIPMENT?

The FDA product code for STEAM STERILIZATION EQUIPMENT 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 Getinge International, Inc. 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.

K920413DECOMAT A 8666K920406DECOMAT 228K821842GAS STERILIZATION EQUIPMENT

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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