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FDA 510(k)

PORTABLE AUTOCLAVES

K-Number: K830931 · 1983-07-27

ApplicantArnold & Sons
Decision Date1983-07-27
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PORTABLE AUTOCLAVES is the device name listed in this FDA 510(k) record. The listed applicant is Arnold & Sons. It received FDA 510(k) clearance on 1983-07-27 under 510(k) number K830931. 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 PORTABLE AUTOCLAVES?

PORTABLE AUTOCLAVES is a medical device that received FDA 510(k) clearance on 1983-07-27. The listed applicant is Arnold & Sons. The 510(k) number is K830931.

When did PORTABLE AUTOCLAVES receive FDA 510(k) clearance?

PORTABLE AUTOCLAVES received FDA 510(k) clearance on 1983-07-27, under 510(k) number K830931.

Who is the listed applicant for PORTABLE AUTOCLAVES?

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

What is the FDA product code for PORTABLE AUTOCLAVES?

The FDA product code for PORTABLE AUTOCLAVES is FLE.

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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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