FDA 510(k)

CKIS-004A INJECTOR SYNCHRONIZATION OPTION

K-Number: K061976 · 2006-09-27

ApplicantToshiba America Medical Systems, In.C

Decision Date2006-09-27

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CKIS-004A INJECTOR SYNCHRONIZATION OPTION 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 2006-09-27 under 510(k) number K061976. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CKIS-004A INJECTOR SYNCHRONIZATION OPTION?

CKIS-004A INJECTOR SYNCHRONIZATION OPTION is a medical device that received FDA 510(k) clearance on 2006-09-27. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K061976.

When did CKIS-004A INJECTOR SYNCHRONIZATION OPTION receive FDA 510(k) clearance?

CKIS-004A INJECTOR SYNCHRONIZATION OPTION received FDA 510(k) clearance on 2006-09-27, under 510(k) number K061976.

Who is the listed applicant for CKIS-004A INJECTOR SYNCHRONIZATION OPTION?

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 CKIS-004A INJECTOR SYNCHRONIZATION OPTION?

The FDA product code for CKIS-004A INJECTOR SYNCHRONIZATION OPTION is DXT.

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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.