FDA 510(k)

TDA-4000/A4

K-Number: K941611 · 1994-05-13

ApplicantToshiba America Medical Systems, In.C

Decision Date1994-05-13

Product CodeJAA

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

TDA-4000/A4 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 K941611. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TDA-4000/A4?

TDA-4000/A4 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 K941611.

When did TDA-4000/A4 receive FDA 510(k) clearance?

TDA-4000/A4 received FDA 510(k) clearance on 1994-05-13, under 510(k) number K941611.

Who is the listed applicant for TDA-4000/A4?

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 TDA-4000/A4?

The FDA product code for TDA-4000/A4 is JAA.

Other records listing Toshiba America Medical Systems, In.C as applicant

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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.