Automated Physiologic Profile Monitor

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K811560 ↗

FDA Product Code

DXG

Device Class

Class II

Regulation

21 CFR Part 870.1435

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Non-Invasive Clinical Vascular Lab

  Class I

  FDA 510(k) K832679 Active Cleared 3 Jan 1984

• Sfa-II Microprocessor-Controlled Module

  Class II

  FDA 510(k) K910905 Active Cleared 24 Jul 1991

• Sfa Module

  Class II

  FDA 510(k) K896528 Active Cleared 26 Jan 1990

• A-V Recorder

  Class II

  FDA 510(k) K873041 Active Cleared 4 Feb 1988

• Mvl/Modulab with Pvr Module

  Class II

  FDA 510(k) K884624 Active Cleared 1 Feb 1989

• Pag Microprocessor-Controlled Module

  Class I

  FDA 510(k) K900365 Active Cleared 18 Jul 1990

See all devices from Life Sciences Manufacturing, Inc. →

• What is the Automated Physiologic Profile Monitor used for?

  The Automated Physiologic Profile Monitor is a computer diagnostic device designed to automatically monitor physiologic profiles. It is specifically intended for cardiovascular use and is pre-programmed for single-function use.

• How is the Automated Physiologic Profile Monitor supplied?

  The device is supplied by Life Sciences Manufacturing, Inc. It is classified as Class II and regulated under product code DXG and 21 CFR 870.1435.

• What is the regulatory status of this device?

  The Automated Physiologic Profile Monitor has FDA 510(k) clearance with the K811560 number. It was received by the FDA on June 2, 1981, and cleared on June 18, 1981, with a decision code of SESE (Substantially Equivalent).

• Is the device reusable or single-use?

  The device is pre-programmed for single-function use, which suggests it is designed for specific monitoring purposes rather than general multi-function use. However, the data does not explicitly state whether it is single-use or reusable.