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FDA 510(k)

NORODYN 2000 ELECTROMYOGRAPH

K-Number: K922838 · 1993-09-22

ApplicantNoromed, Inc.
Decision Date1993-09-22
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NORODYN 2000 ELECTROMYOGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is Noromed, Inc.. It received FDA 510(k) clearance on 1993-09-22 under 510(k) number K922838. The device is classified under product code HCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NORODYN 2000 ELECTROMYOGRAPH?

NORODYN 2000 ELECTROMYOGRAPH is a medical device that received FDA 510(k) clearance on 1993-09-22. The listed applicant is Noromed, Inc.. The 510(k) number is K922838.

When did NORODYN 2000 ELECTROMYOGRAPH receive FDA 510(k) clearance?

NORODYN 2000 ELECTROMYOGRAPH received FDA 510(k) clearance on 1993-09-22, under 510(k) number K922838.

Who is the listed applicant for NORODYN 2000 ELECTROMYOGRAPH?

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

What is the FDA product code for NORODYN 2000 ELECTROMYOGRAPH?

The FDA product code for NORODYN 2000 ELECTROMYOGRAPH is HCC.

Related Clinical Trials

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Other records listing Noromed, Inc. as applicant

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.

K920690NOROTRACK 360 INCLINOMETER

Related Devices (Code: HCC)

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

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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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