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FDA 510(k)

NEUROLOGY ACCESSORIES - MARK-EASY 10-20

K-Number: K942461 · 1994-10-19

ApplicantOptimit USA, Inc.
Decision Date1994-10-19
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROLOGY ACCESSORIES - MARK-EASY 10-20 is the device name listed in this FDA 510(k) record. The listed applicant is Optimit USA, Inc.. It received FDA 510(k) clearance on 1994-10-19 under 510(k) number K942461. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEUROLOGY ACCESSORIES - MARK-EASY 10-20?

NEUROLOGY ACCESSORIES - MARK-EASY 10-20 is a medical device that received FDA 510(k) clearance on 1994-10-19. The listed applicant is Optimit USA, Inc.. The 510(k) number is K942461.

When did NEUROLOGY ACCESSORIES - MARK-EASY 10-20 receive FDA 510(k) clearance?

NEUROLOGY ACCESSORIES - MARK-EASY 10-20 received FDA 510(k) clearance on 1994-10-19, under 510(k) number K942461.

Who is the listed applicant for NEUROLOGY ACCESSORIES - MARK-EASY 10-20?

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

What is the FDA product code for NEUROLOGY ACCESSORIES - MARK-EASY 10-20?

The FDA product code for NEUROLOGY ACCESSORIES - MARK-EASY 10-20 is GXY.

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Related Devices (Code: GXY)

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Official Source

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