Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3

by Edan Instruments, Inc.

510(k) K173042

Listed No authorization on record

Valid until

Not applicable

No authorization on record

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 7 Oct 2026. What this means

Specification

510(k)

510(k) Number: K173042
FDA Product Code: HGM
Models / Variants: Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express
Fetal Monitor: Models F2, F3

Device Class: Class II
Regulation: 21 CFR Part 884.2740
Advisory Committee: Obstetrics/Gynecology
FDA Decision: SESE Substantially Equivalent

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