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FDA 510(k)

MEDIVISION IGS SYSTEM

K-Number: K003699 · 2001-02-27

ApplicantMedivision (U.S.A.), Inc.
Decision Date2001-02-27
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MEDIVISION IGS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medivision (U.S.A.), Inc.. It received FDA 510(k) clearance on 2001-02-27 under 510(k) number K003699. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDIVISION IGS SYSTEM?

MEDIVISION IGS SYSTEM is a medical device that received FDA 510(k) clearance on 2001-02-27. The listed applicant is Medivision (U.S.A.), Inc.. The 510(k) number is K003699.

When did MEDIVISION IGS SYSTEM receive FDA 510(k) clearance?

MEDIVISION IGS SYSTEM received FDA 510(k) clearance on 2001-02-27, under 510(k) number K003699.

Who is the listed applicant for MEDIVISION IGS SYSTEM?

The FDA 510(k) record lists Medivision (U.S.A.), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDIVISION IGS SYSTEM?

The FDA product code for MEDIVISION IGS SYSTEM is HAW.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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