Hewlett-Packard Cardiac Catheterization Recording

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K921194 ↗

FDA Product Code

DRT

Device Class

Class II

Regulation

21 CFR Part 870.2300

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Luer Lock Skirt

  Class II

  FDA 510(k) K862451 Active Cleared 31 Oct 1986

• Hp Sonos 100 Cf Ultrasound Imaging System

  Class II

  FDA 510(k) K922184 Active Cleared 30 Jul 1992

• Medical Diag. Ultrasound Instr. 77065

  Class II

  FDA 510(k) K842897 Active Cleared 25 Sep 1984

• Model M1403A Telemetry Monitoring Systems (TMS)

  Class II

  FDA 510(k) K913533 Active Cleared 7 Nov 1991

• Differential Refractive Index Detector

  Class I

  FDA 510(k) K800556 Active Cleared 25 Mar 1980

• Model 80100A, Patient Data Memory

  Class II

  FDA 510(k) K781360 Active Cleared 7 Sep 1978

See all devices from Hewlett-Packard Co. →

• What is the Hewlett-Packard Cardiac Catheterization Recording used for?

  The device is a cardiac monitor that includes a cardiotachometer and rate alarm, used to measure heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor during cardiovascular procedures.

• Is the Hewlett-Packard Cardiac Catheterization Recording supplied as a single-use or reusable device?

  The device is supplied as a single-use unit, as explicitly stated in the description, and is not specified as reusable.

• What regulatory pathway was used for the Hewlett-Packard Cardiac Catheterization Recording?

  The device received authorization through the FDA 510(k) process, as indicated in the AUTHORIZATIONS field, and was found substantially equivalent (SESE) on November 9, 1992.

• Is the Hewlett-Packard Cardiac Catheterization Recording sterile or MRI-safe?

  The device is not specified as sterile or MRI-safe in the provided data; no claims regarding sterility or MRI compatibility are made.

• What are the storage requirements for the Hewlett-Packard Cardiac Catheterization Recording?

  Storage requirements are not provided in the device data, so no specific storage conditions can be inferred or stated.