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FDA 510(k)

MODEL U-1000 WITH GESTATIONAL AGE CALCULATION

K-Number: K871385 · 1987-05-26

ApplicantFukuda Denshi USA, Inc.
Decision Date1987-05-26
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MODEL U-1000 WITH GESTATIONAL AGE CALCULATION is the device name listed in this FDA 510(k) record. The listed applicant is Fukuda Denshi USA, Inc.. It received FDA 510(k) clearance on 1987-05-26 under 510(k) number K871385. The device is classified under product code HGM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL U-1000 WITH GESTATIONAL AGE CALCULATION?

MODEL U-1000 WITH GESTATIONAL AGE CALCULATION is a medical device that received FDA 510(k) clearance on 1987-05-26. The listed applicant is Fukuda Denshi USA, Inc.. The 510(k) number is K871385.

When did MODEL U-1000 WITH GESTATIONAL AGE CALCULATION receive FDA 510(k) clearance?

MODEL U-1000 WITH GESTATIONAL AGE CALCULATION received FDA 510(k) clearance on 1987-05-26, under 510(k) number K871385.

Who is the listed applicant for MODEL U-1000 WITH GESTATIONAL AGE CALCULATION?

The FDA 510(k) record lists Fukuda Denshi USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL U-1000 WITH GESTATIONAL AGE CALCULATION?

The FDA product code for MODEL U-1000 WITH GESTATIONAL AGE CALCULATION is HGM.

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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.

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