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FDA 510(k)

SAPPHIRE 4ME EMG/EP SYSTEM

K-Number: K912775 · 1991-11-08

ApplicantMedelec Intl. Corp.
Decision Date1991-11-08
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SAPPHIRE 4ME EMG/EP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medelec Intl. Corp.. It received FDA 510(k) clearance on 1991-11-08 under 510(k) number K912775. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAPPHIRE 4ME EMG/EP SYSTEM?

SAPPHIRE 4ME EMG/EP SYSTEM is a medical device that received FDA 510(k) clearance on 1991-11-08. The listed applicant is Medelec Intl. Corp.. The 510(k) number is K912775.

When did SAPPHIRE 4ME EMG/EP SYSTEM receive FDA 510(k) clearance?

SAPPHIRE 4ME EMG/EP SYSTEM received FDA 510(k) clearance on 1991-11-08, under 510(k) number K912775.

Who is the listed applicant for SAPPHIRE 4ME EMG/EP SYSTEM?

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

What is the FDA product code for SAPPHIRE 4ME EMG/EP SYSTEM?

The FDA product code for SAPPHIRE 4ME EMG/EP SYSTEM is GWF.

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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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