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Model U-1000 With Gestational Age Calculation

FDA 510(k)

Class II (US FDA 510(k))

510(k) K871385

by Fukuda Denshi Usa, Inc.

Identifiers

510(k) Number
K871385 FDA 510(k)
FDA Product Code
HGM FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 884.2740 FDA 510(k)
Regulation Number
884.2740 FDA 510(k)
Advisory Committee
Obstetrics/Gynecology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Model U-1000 With Gestational Age Calculation is a System, Monitoring, Perinatal device as defined by its device type and classification. It is designed for monitoring perinatal patients and includes gestational age calculation functionality.

This device was cleared through the FDA 510(k) process under K871385, with a decision date of May 26, 1987. It is classified as Class II under product code HGM and regulation number 884.2740, and was manufactured by Fukuda Denshi USA, Inc. in Kirkland, WA.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MODEL U-1000 WITH GESTATIONAL AGE CALCULATION (K871385) — FDA 510 (k ..., K871385 FDA 510(k) - MODEL U-1000 WITH GESTATIONAL AGE CALCU..., K871385 FDA 510(k) - MODEL U-1000 WITH GESTATIONAL AGE CALCU..., MODEL U-1000 ULTRASONIC SCANNER (K851902) — FDA 510 (k) - Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Fukuda Denshi Usa, Inc.

Sources (1)

  • FDA 510(k) K871385 24 fields · synced Sep 26, 2026