FDA 510(k)

CAPASEE

K-Number: K933747 · 1994-05-13

ApplicantToshiba America Medical Systems, In.C

Decision Date1994-05-13

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CAPASEE is the device name listed in this FDA 510(k) record. The listed applicant is Toshiba America Medical Systems, In.C. It received FDA 510(k) clearance on 1994-05-13 under 510(k) number K933747. 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 CAPASEE?

CAPASEE is a medical device that received FDA 510(k) clearance on 1994-05-13. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K933747.

When did CAPASEE receive FDA 510(k) clearance?

CAPASEE received FDA 510(k) clearance on 1994-05-13, under 510(k) number K933747.

Who is the listed applicant for CAPASEE?

The FDA 510(k) record lists Toshiba America Medical Systems, In.C as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAPASEE?

The FDA product code for CAPASEE 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.