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FDA 510(k)

ARISTOSURG 250

K-Number: K800395 · 1980-03-17

ApplicantHalmon-Locren, Inc.
Decision Date1980-03-17
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ARISTOSURG 250 is the device name listed in this FDA 510(k) record. The listed applicant is Halmon-Locren, Inc.. It received FDA 510(k) clearance on 1980-03-17 under 510(k) number K800395. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARISTOSURG 250?

ARISTOSURG 250 is a medical device that received FDA 510(k) clearance on 1980-03-17. The listed applicant is Halmon-Locren, Inc.. The 510(k) number is K800395.

When did ARISTOSURG 250 receive FDA 510(k) clearance?

ARISTOSURG 250 received FDA 510(k) clearance on 1980-03-17, under 510(k) number K800395.

Who is the listed applicant for ARISTOSURG 250?

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

What is the FDA product code for ARISTOSURG 250?

The FDA product code for ARISTOSURG 250 is EIA.

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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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