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FDA 510(k)

ASC-954 INTEGRATOR AMPLIFIER

K-Number: K896164 · 1990-01-22

ApplicantAstro-Med, Inc.
Decision Date1990-01-22
Product CodeGWK
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ASC-954 INTEGRATOR AMPLIFIER is the device name listed in this FDA 510(k) record. The listed applicant is Astro-Med, Inc.. It received FDA 510(k) clearance on 1990-01-22 under 510(k) number K896164. The device is classified under product code GWK. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASC-954 INTEGRATOR AMPLIFIER?

ASC-954 INTEGRATOR AMPLIFIER is a medical device that received FDA 510(k) clearance on 1990-01-22. The listed applicant is Astro-Med, Inc.. The 510(k) number is K896164.

When did ASC-954 INTEGRATOR AMPLIFIER receive FDA 510(k) clearance?

ASC-954 INTEGRATOR AMPLIFIER received FDA 510(k) clearance on 1990-01-22, under 510(k) number K896164.

Who is the listed applicant for ASC-954 INTEGRATOR AMPLIFIER?

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

What is the FDA product code for ASC-954 INTEGRATOR AMPLIFIER?

The FDA product code for ASC-954 INTEGRATOR AMPLIFIER is GWK.

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Other records listing Astro-Med, Inc. as applicant

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Related Devices (Code: GWK)

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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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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