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FDA 510(k)

MEGA MEDITEX LIMITED

K-Number: K950622 · 1995-06-02

ApplicantMega Meditex , Ltd.
Decision Date1995-06-02
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MEGA MEDITEX LIMITED is the device name listed in this FDA 510(k) record. The listed applicant is Mega Meditex , Ltd.. It received FDA 510(k) clearance on 1995-06-02 under 510(k) number K950622. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEGA MEDITEX LIMITED?

MEGA MEDITEX LIMITED is a medical device that received FDA 510(k) clearance on 1995-06-02. The listed applicant is Mega Meditex , Ltd.. The 510(k) number is K950622.

When did MEGA MEDITEX LIMITED receive FDA 510(k) clearance?

MEGA MEDITEX LIMITED received FDA 510(k) clearance on 1995-06-02, under 510(k) number K950622.

Who is the listed applicant for MEGA MEDITEX LIMITED?

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

What is the FDA product code for MEGA MEDITEX LIMITED?

The FDA product code for MEGA MEDITEX LIMITED is LYY.

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Official Source

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