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FDA 510(k)

MEGA ME 3000 PROFESSIONAL MUSCLE TESTER

K-Number: K963202 · 1997-05-19

ApplicantMega Electronics , Ltd.
Decision Date1997-05-19
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MEGA ME 3000 PROFESSIONAL MUSCLE TESTER is the device name listed in this FDA 510(k) record. The listed applicant is Mega Electronics , Ltd.. It received FDA 510(k) clearance on 1997-05-19 under 510(k) number K963202. 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 MEGA ME 3000 PROFESSIONAL MUSCLE TESTER?

MEGA ME 3000 PROFESSIONAL MUSCLE TESTER is a medical device that received FDA 510(k) clearance on 1997-05-19. The listed applicant is Mega Electronics , Ltd.. The 510(k) number is K963202.

When did MEGA ME 3000 PROFESSIONAL MUSCLE TESTER receive FDA 510(k) clearance?

MEGA ME 3000 PROFESSIONAL MUSCLE TESTER received FDA 510(k) clearance on 1997-05-19, under 510(k) number K963202.

Who is the listed applicant for MEGA ME 3000 PROFESSIONAL MUSCLE TESTER?

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

What is the FDA product code for MEGA ME 3000 PROFESSIONAL MUSCLE TESTER?

The FDA product code for MEGA ME 3000 PROFESSIONAL MUSCLE TESTER is HCC.

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Other records listing Mega Electronics , Ltd. 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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