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Gravidaphone

by Solar Electronics

510(k) K802024

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK802024 Date7 Jan 1981ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KNG
Device Class
Class II
Regulation
21 CFR Part 884.2660
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Gravidaphone is an ultrasonic fetal monitor. It is designed to monitor fetal heart rate and activity during pregnancy.

This device is classified as a Class 2 medical device under regulation number 884.2660. It received FDA 510(k) clearance under K802024.

Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the Gravidaphone?

    The Gravidaphone is an ultrasonic fetal monitor intended to track and monitor fetal heart rate and fetal activity throughout the course of a pregnancy.

  • What is the regulatory classification of this device?

    The Gravidaphone is classified as a Class 2 medical device under regulation number 884.2660. It received FDA 510(k) clearance under submission number K802024.

  • Which medical specialty is this device associated with?

    This device is categorized under the Obstetrics and Gynecology medical specialty, as it is specifically designed for monitoring fetal health during the gestational period.