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FDA 510(k)

EAGLE 3000 SDS

K-Number: K912471 · 1992-06-26

ApplicantAmsco Co.
Decision Date1992-06-26
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EAGLE 3000 SDS is the device name listed in this FDA 510(k) record. The listed applicant is Amsco Co.. It received FDA 510(k) clearance on 1992-06-26 under 510(k) number K912471. 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 EAGLE 3000 SDS?

EAGLE 3000 SDS is a medical device that received FDA 510(k) clearance on 1992-06-26. The listed applicant is Amsco Co.. The 510(k) number is K912471.

When did EAGLE 3000 SDS receive FDA 510(k) clearance?

EAGLE 3000 SDS received FDA 510(k) clearance on 1992-06-26, under 510(k) number K912471.

Who is the listed applicant for EAGLE 3000 SDS?

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

What is the FDA product code for EAGLE 3000 SDS?

The FDA product code for EAGLE 3000 SDS is FLE.

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Other records listing Amsco 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.

K854922AMSCO POLARIS SLK833187HALL OSTEONK832945EAGLE 2000 STERILIZER SERIES GAS/AERAK832187HALL OSCILLATORK832186HALL DRILL/REAMERK832188HALL RECIPROCATOR

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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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