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Telemanometer

by R.J. Ash, Medical Monitoring, Inc.

510(k) K850166

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 NumberK850166 Date18 Apr 1985ClearedStatusActive

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  • Withdrawn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
DRG
Device Class
Class II
Regulation
21 CFR Part 870.2910
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Telemanometer is a transmitter and receiver for physiological signal, radiofrequency. It is classified as a device for cardiovascular medical specialty.

The Telemanometer is supplied with a product code of DRG and is regulated under 21 CFR 870.2910. It has been authorized by the FDA with a 510K clearance, specifically K850166. The device is manufactured by R.J. Ash, Medical Monitoring, Inc.

Questions

AI-generated answers, 1 Oct 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 Telemanometer used for?

    The Telemanometer is used for transmitting and receiving physiological signals, specifically in the cardiovascular medical specialty.

  • Is the Telemanometer supplied sterile?

    The device data does not specify if the Telemanometer is supplied sterile, it is recommended to consult the manufacturer's instructions for use.

  • What is the regulatory classification of the Telemanometer?

    The Telemanometer is regulated under 21 CFR 870.2910 and has been authorized by the FDA with a 510K clearance, specifically K850166.