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FDA 510(k)

COMPUMEDICS SUMMIT IP

K-Number: K040194 · 2004-04-23

ApplicantCompumedics USA, Ltd.
Decision Date2004-04-23
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

COMPUMEDICS SUMMIT IP is the device name listed in this FDA 510(k) record. The listed applicant is Compumedics USA, Ltd.. It received FDA 510(k) clearance on 2004-04-23 under 510(k) number K040194. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPUMEDICS SUMMIT IP?

COMPUMEDICS SUMMIT IP is a medical device that received FDA 510(k) clearance on 2004-04-23. The listed applicant is Compumedics USA, Ltd.. The 510(k) number is K040194.

When did COMPUMEDICS SUMMIT IP receive FDA 510(k) clearance?

COMPUMEDICS SUMMIT IP received FDA 510(k) clearance on 2004-04-23, under 510(k) number K040194.

Who is the listed applicant for COMPUMEDICS SUMMIT IP?

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

What is the FDA product code for COMPUMEDICS SUMMIT IP?

The FDA product code for COMPUMEDICS SUMMIT IP is MNR.

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Other records listing Compumedics USA, Ltd. as applicant

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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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