FDA 510(k)

SSH-140A FETAL DOPPLER SYSTEM

K-Number: K931293 · 1994-02-09

ApplicantToshiba America Medical Systems, In.C

Decision Date1994-02-09

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SSH-140A FETAL DOPPLER SYSTEM 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 1994-02-09 under 510(k) number K931293. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SSH-140A FETAL DOPPLER SYSTEM?

SSH-140A FETAL DOPPLER SYSTEM is a medical device that received FDA 510(k) clearance on 1994-02-09. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K931293.

When did SSH-140A FETAL DOPPLER SYSTEM receive FDA 510(k) clearance?

SSH-140A FETAL DOPPLER SYSTEM received FDA 510(k) clearance on 1994-02-09, under 510(k) number K931293.

Who is the listed applicant for SSH-140A FETAL DOPPLER SYSTEM?

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 SSH-140A FETAL DOPPLER SYSTEM?

The FDA product code for SSH-140A FETAL DOPPLER SYSTEM is IYN.

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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.