Heart Rate/Respiration Simulator 8310

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

510(k) Number

K841363 ↗

FDA Product Code

DRT

Device Class

Class II

Regulation

21 CFR Part 870.2300

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Model 6213 Remote Alarm

  Class II

  FDA 510(k) K914424 Active Cleared 10 Sep 1992

• Portable Oxygen Generator

  Class II

  FDA 510(k) K915381 Active Cleared 11 Mar 1992

• Model Number 8200 Respiration/Heart Rate Monitor

  Class II

  FDA 510(k) K871551 Active Cleared 5 Jun 1987

• External Uterine Contraction Monitor-Tokodynamomet

  Class II

  FDA 510(k) K853856 Active Cleared 12 Mar 1986

• Model 9101 Recorder/Analyzer System

  Class II

  FDA 510(k) K901251 Active Cleared 22 May 1990

• Model 9216 Respiration/Heart Rate Monitor

  Class II

  FDA 510(k) K881266 Active Cleared 10 Jun 1988

See all devices from Aequitron Medical, Inc. →

• What is the primary purpose of the Heart Rate/Respiration Simulator 8310 in a clinical setting?

  The Heart Rate/Respiration Simulator 8310 is designed to simulate human heart rate and respiration activity, serving as a test tool to validate and calibrate cardiac monitoring equipment. This ensures that devices measuring heart rate and respiration provide accurate and reliable readings in healthcare environments.

• Is the Heart Rate/Respiration Simulator 8310 intended for single-use or reusable applications?

  The device is supplied as a reusable medical instrument, meaning it is not meant for single-use and does not require sterilization between uses. This makes it cost-effective for repeated testing and calibration of cardiac monitoring systems.

• What regulatory pathway was followed for the FDA clearance of this device, and what classification does it hold?

  The Heart Rate/Respiration Simulator 8310 received FDA clearance through a 510(k) premarket notification process, specifically under the traditional clearance type. It is classified as a Class II device under regulation number 870.2300, with the product code DRT, and was reviewed by the Cardiovascular (CV) advisory committee.

• Are there any variations in size or MRI safety considerations for this simulator?

  The available data does not specify any variations in size for the Heart Rate/Respiration Simulator 8310, nor does it mention any MRI safety considerations. This means the device is not designed for use in MRI environments, and a single standardized model is implied.