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FDA 510(k)

METRACO EVOKED POTENTIAL SYSTEM

K-Number: K821250 · 1982-07-02

ApplicantMetraco, Inc.
Decision Date1982-07-02
Product CodeGWL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

METRACO EVOKED POTENTIAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Metraco, Inc.. It received FDA 510(k) clearance on 1982-07-02 under 510(k) number K821250. 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 METRACO EVOKED POTENTIAL SYSTEM?

METRACO EVOKED POTENTIAL SYSTEM is a medical device that received FDA 510(k) clearance on 1982-07-02. The listed applicant is Metraco, Inc.. The 510(k) number is K821250.

When did METRACO EVOKED POTENTIAL SYSTEM receive FDA 510(k) clearance?

METRACO EVOKED POTENTIAL SYSTEM received FDA 510(k) clearance on 1982-07-02, under 510(k) number K821250.

Who is the listed applicant for METRACO EVOKED POTENTIAL SYSTEM?

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

What is the FDA product code for METRACO EVOKED POTENTIAL SYSTEM?

The FDA product code for METRACO EVOKED POTENTIAL SYSTEM is GWL.

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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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