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FDA 510(k)

STERILIZER, EAGLE 2000

K-Number: K781684 · 1978-10-24

ApplicantAmerican Sterilizer Co.
Decision Date1978-10-24
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERILIZER, EAGLE 2000 is the device name listed in this FDA 510(k) record. The listed applicant is American Sterilizer Co.. It received FDA 510(k) clearance on 1978-10-24 under 510(k) number K781684. 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 STERILIZER, EAGLE 2000?

STERILIZER, EAGLE 2000 is a medical device that received FDA 510(k) clearance on 1978-10-24. The listed applicant is American Sterilizer Co.. The 510(k) number is K781684.

When did STERILIZER, EAGLE 2000 receive FDA 510(k) clearance?

STERILIZER, EAGLE 2000 received FDA 510(k) clearance on 1978-10-24, under 510(k) number K781684.

Who is the listed applicant for STERILIZER, EAGLE 2000?

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

What is the FDA product code for STERILIZER, EAGLE 2000?

The FDA product code for STERILIZER, EAGLE 2000 is FLE.

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Other records listing American Sterilizer Co. 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.

K943288AMSCO SQ240 SURGICAL LIGHTK931872THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZERK922485CHEMDI-VHP CHEMICAL INDICATORK930493QUANTUM 3080 SURGICAL TABLEK905816ORTHOVISION TABLEK896674AMSCO QUANTUM LIGHT

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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