Skip to content

Medi-Dyne Apnea Monitor

by Med Dyne Inst., Inc.

510(k) K760635

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK760635 Date21 Sep 1976ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
FLS
Device Class
Class II
Regulation
21 CFR Part 868.2377
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Medi-Dyne Apnea Monitor is a device designed to detect apnea, or pauses in breathing, by monitoring physiological parameters such as heart rate. It is intended for facility use and is classified as a Class II medical device under FDA regulation 868.2377.

The device is supplied as a single-use or reusable unit, depending on the model, and requires proper storage in a controlled environment. It is cleared for use via FDA 510(k) notification K760635 and is reviewed by the Anesthesiology advisory committee.

Questions

AI-generated answers, 23 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 Medi-Dyne Apnea Monitor used for?

    This device is designed to detect apnea, which are pauses in breathing, by monitoring physiological parameters such as heart rate. It is intended for use in a facility setting.

  • Is the Medi-Dyne Apnea Monitor a single-use or reusable device?

    The device is supplied as a single-use or reusable unit, depending on the specific model. Please refer to the product packaging or manufacturer documentation for the specific model's usage instructions.

  • What is the regulatory status of the Medi-Dyne Apnea Monitor?

    The Medi-Dyne Apnea Monitor is a Class II medical device cleared for use via FDA 510(k) notification with number K760635. It is reviewed by the Anesthesiology advisory committee.