FDA 510(k)

SDL-32 ELECTRONIC LINEAR SCANNER

K-Number: K850834 · 1985-10-31

Decision Date1985-10-31

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SDL-32 ELECTRONIC LINEAR SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Shimadzu Corp.. It received FDA 510(k) clearance on 1985-10-31 under 510(k) number K850834. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SDL-32 ELECTRONIC LINEAR SCANNER?

SDL-32 ELECTRONIC LINEAR SCANNER is a medical device that received FDA 510(k) clearance on 1985-10-31. The listed applicant is Shimadzu Corp.. The 510(k) number is K850834.

When did SDL-32 ELECTRONIC LINEAR SCANNER receive FDA 510(k) clearance?

SDL-32 ELECTRONIC LINEAR SCANNER received FDA 510(k) clearance on 1985-10-31, under 510(k) number K850834.

Who is the listed applicant for SDL-32 ELECTRONIC LINEAR SCANNER?

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

What is the FDA product code for SDL-32 ELECTRONIC LINEAR SCANNER?

The FDA product code for SDL-32 ELECTRONIC LINEAR SCANNER is IYO.

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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.