FDA 510(k)

SAND S MB12 MAMMOGRAPHY MOVING GRID BUCKY

K-Number: K850614 · 1985-03-26

Decision Date1985-03-26

Product CodeIZH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SAND S MB12 MAMMOGRAPHY MOVING GRID BUCKY is the device name listed in this FDA 510(k) record. The listed applicant is S & S X-Ray Products, Inc.. It received FDA 510(k) clearance on 1985-03-26 under 510(k) number K850614. The device is classified under product code IZH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAND S MB12 MAMMOGRAPHY MOVING GRID BUCKY?

SAND S MB12 MAMMOGRAPHY MOVING GRID BUCKY is a medical device that received FDA 510(k) clearance on 1985-03-26. The listed applicant is S & S X-Ray Products, Inc.. The 510(k) number is K850614.

When did SAND S MB12 MAMMOGRAPHY MOVING GRID BUCKY receive FDA 510(k) clearance?

SAND S MB12 MAMMOGRAPHY MOVING GRID BUCKY received FDA 510(k) clearance on 1985-03-26, under 510(k) number K850614.

Who is the listed applicant for SAND S MB12 MAMMOGRAPHY MOVING GRID BUCKY?

The FDA 510(k) record lists S & S X-Ray Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAND S MB12 MAMMOGRAPHY MOVING GRID BUCKY?

The FDA product code for SAND S MB12 MAMMOGRAPHY MOVING GRID BUCKY is IZH.

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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.