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FDA 510(k)

VOLUME NECK COIL FOR THE GYREX V-DIX

K-Number: K935224 · 1994-06-27

ApplicantElscint, Inc.
Decision Date1994-06-27
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VOLUME NECK COIL FOR THE GYREX V-DIX is the device name listed in this FDA 510(k) record. The listed applicant is Elscint, Inc.. It received FDA 510(k) clearance on 1994-06-27 under 510(k) number K935224. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VOLUME NECK COIL FOR THE GYREX V-DIX?

VOLUME NECK COIL FOR THE GYREX V-DIX is a medical device that received FDA 510(k) clearance on 1994-06-27. The listed applicant is Elscint, Inc.. The 510(k) number is K935224.

When did VOLUME NECK COIL FOR THE GYREX V-DIX receive FDA 510(k) clearance?

VOLUME NECK COIL FOR THE GYREX V-DIX received FDA 510(k) clearance on 1994-06-27, under 510(k) number K935224.

Who is the listed applicant for VOLUME NECK COIL FOR THE GYREX V-DIX?

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

What is the FDA product code for VOLUME NECK COIL FOR THE GYREX V-DIX?

The FDA product code for VOLUME NECK COIL FOR THE GYREX V-DIX is LNH.

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Other records listing Elscint, Inc. as applicant

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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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