FDA 510(k)

EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE

K-Number: K900966 · 1990-09-12

ApplicantHitachi Medical Corp. of America

Decision Date1990-09-12

Product CodeHGL

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Medical Corp. of America. It received FDA 510(k) clearance on 1990-09-12 under 510(k) number K900966. The device is classified under product code HGL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE?

EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE is a medical device that received FDA 510(k) clearance on 1990-09-12. The listed applicant is Hitachi Medical Corp. of America. The 510(k) number is K900966.

When did EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE receive FDA 510(k) clearance?

EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE received FDA 510(k) clearance on 1990-09-12, under 510(k) number K900966.

Who is the listed applicant for EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE?

The FDA 510(k) record lists Hitachi Medical Corp. of America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE?

The FDA product code for EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE is HGL.

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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.