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FDA 510(k)

PATHWAY ELECTROMYOGRAPH MODEL PATHWAY II/MR-10/MR-15/MR-20/MR-25

K-Number: K960508 · 1997-01-16

ApplicantThe Prometheus Group
Decision Date1997-01-16
Product CodeHIR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PATHWAY ELECTROMYOGRAPH MODEL PATHWAY II/MR-10/MR-15/MR-20/MR-25 is the device name listed in this FDA 510(k) record. The listed applicant is The Prometheus Group. It received FDA 510(k) clearance on 1997-01-16 under 510(k) number K960508. The device is classified under product code HIR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATHWAY ELECTROMYOGRAPH MODEL PATHWAY II/MR-10/MR-15/MR-20/MR-25?

PATHWAY ELECTROMYOGRAPH MODEL PATHWAY II/MR-10/MR-15/MR-20/MR-25 is a medical device that received FDA 510(k) clearance on 1997-01-16. The listed applicant is The Prometheus Group. The 510(k) number is K960508.

When did PATHWAY ELECTROMYOGRAPH MODEL PATHWAY II/MR-10/MR-15/MR-20/MR-25 receive FDA 510(k) clearance?

PATHWAY ELECTROMYOGRAPH MODEL PATHWAY II/MR-10/MR-15/MR-20/MR-25 received FDA 510(k) clearance on 1997-01-16, under 510(k) number K960508.

Who is the listed applicant for PATHWAY ELECTROMYOGRAPH MODEL PATHWAY II/MR-10/MR-15/MR-20/MR-25?

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

What is the FDA product code for PATHWAY ELECTROMYOGRAPH MODEL PATHWAY II/MR-10/MR-15/MR-20/MR-25?

The FDA product code for PATHWAY ELECTROMYOGRAPH MODEL PATHWAY II/MR-10/MR-15/MR-20/MR-25 is HIR.

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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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