FDA 510(k)

TOMOMATIC 564

K-Number: K850416 · 1985-09-20

Decision Date1985-09-20

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

TOMOMATIC 564 is the device name listed in this FDA 510(k) record. The listed applicant is M.I.D., Inc.. It received FDA 510(k) clearance on 1985-09-20 under 510(k) number K850416. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOMOMATIC 564?

TOMOMATIC 564 is a medical device that received FDA 510(k) clearance on 1985-09-20. The listed applicant is M.I.D., Inc.. The 510(k) number is K850416.

When did TOMOMATIC 564 receive FDA 510(k) clearance?

TOMOMATIC 564 received FDA 510(k) clearance on 1985-09-20, under 510(k) number K850416.

Who is the listed applicant for TOMOMATIC 564?

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

What is the FDA product code for TOMOMATIC 564?

The FDA product code for TOMOMATIC 564 is KPS.

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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.