Infant Cardiac Monitor

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

Full name

Infant Caridac Monitor

510(k) Number

K812674 ↗

FDA Product Code

DRT

Device Class

Class II

Regulation

21 CFR Part 870.2300

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Edec 2000

  Class I

  FDA 510(k) K852908 Active Cleared 29 Nov 1985

• Edec 90C

  Class I

  FDA 510(k) K875342 Active Cleared 29 Jan 1988

• View Reading Station

  Class II

  FDA 510(k) K003688 Active Cleared 22 Jan 2001

• Edec 60 R/F

  Class I

  FDA 510(k) K875341 Active Cleared 1 Feb 1988

• Em Tens Window Electrodes

  Class II

  FDA 510(k) K864032 Active Cleared 22 Dec 1986

• Edec 60R

  Class I

  FDA 510(k) K880050 Active Cleared 29 Feb 1988

See all devices from Electromed Intl., Ltd. →

• What is the Infant Cardiac Monitor used for?

  The Infant Cardiac Monitor is designed to monitor cardiac function in infants, featuring cardiotachometer and rate alarm capabilities to track heart rate and alert to any abnormalities in cardiovascular settings.

• How is the Infant Cardiac Monitor supplied?

  The device is supplied for use in cardiovascular settings and is classified as a Class II medical device. It is manufactured by Electromed Intl., Ltd. and is not indicated as MRI safe or single-use.

• What is the regulatory status of the Infant Cardiac Monitor?

  The Infant Cardiac Monitor is authorized under FDA 510K clearance with the product code DRT and regulation number 870.2300. It is classified as a Class II medical device and is not indicated as MRI safe or single-use.

• What are the specifications of the Infant Cardiac Monitor?

  The Infant Cardiac Monitor includes features such as cardiotachometer and rate alarm capabilities to track heart rate and alert to any abnormalities. It is designed for monitoring cardiac function in infants and is supplied for use in cardiovascular settings.