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FDA 510(k)

AM-PAK

K-Number: K912436 · 1991-10-18

ApplicantCns, Inc.
Decision Date1991-10-18
Product CodeGWL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AM-PAK is the device name listed in this FDA 510(k) record. The listed applicant is Cns, Inc.. It received FDA 510(k) clearance on 1991-10-18 under 510(k) number K912436. The device is classified under product code GWL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AM-PAK?

AM-PAK is a medical device that received FDA 510(k) clearance on 1991-10-18. The listed applicant is Cns, Inc.. The 510(k) number is K912436.

When did AM-PAK receive FDA 510(k) clearance?

AM-PAK received FDA 510(k) clearance on 1991-10-18, under 510(k) number K912436.

Who is the listed applicant for AM-PAK?

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

What is the FDA product code for AM-PAK?

The FDA product code for AM-PAK is GWL.

Other records listing Cns, Inc. as applicant

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Related Devices (Code: GWL)

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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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