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FDA 510(k)

MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE

K-Number: K970051 · 1997-07-10

ApplicantSmith and Nephew Donjoy, Inc.
Decision Date1997-07-10
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Smith and Nephew Donjoy, Inc.. It received FDA 510(k) clearance on 1997-07-10 under 510(k) number K970051. 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 MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE?

MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE is a medical device that received FDA 510(k) clearance on 1997-07-10. The listed applicant is Smith and Nephew Donjoy, Inc.. The 510(k) number is K970051.

When did MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE receive FDA 510(k) clearance?

MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE received FDA 510(k) clearance on 1997-07-10, under 510(k) number K970051.

Who is the listed applicant for MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE?

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

What is the FDA product code for MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE?

The FDA product code for MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE is HCC.

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Other records listing Smith and Nephew Donjoy, 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.

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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

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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