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FDA 510(k)

A BREAST COIL FOR THE GYREX 2T-DIX

K-Number: K923897 · 1992-10-21

ApplicantElscint, Inc.
Decision Date1992-10-21
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

A BREAST COIL FOR THE GYREX 2T-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 1992-10-21 under 510(k) number K923897. 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 A BREAST COIL FOR THE GYREX 2T-DIX?

A BREAST COIL FOR THE GYREX 2T-DIX is a medical device that received FDA 510(k) clearance on 1992-10-21. The listed applicant is Elscint, Inc.. The 510(k) number is K923897.

When did A BREAST COIL FOR THE GYREX 2T-DIX receive FDA 510(k) clearance?

A BREAST COIL FOR THE GYREX 2T-DIX received FDA 510(k) clearance on 1992-10-21, under 510(k) number K923897.

Who is the listed applicant for A BREAST COIL FOR THE GYREX 2T-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 A BREAST COIL FOR THE GYREX 2T-DIX?

The FDA product code for A BREAST COIL FOR THE GYREX 2T-DIX is LNH.

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Other records listing Elscint, Inc. as applicant

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Related Devices (Code: LNH)

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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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