LifeBed Network Patient Vigilance System

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

510(k) Number

K100745 ↗

FDA Product Code

DRT

Device Class

Class II

Regulation

21 CFR Part 870.2300

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Lifegurney Network Patient Vigilance System

  Class II

  FDA 510(k) K092037 Active Cleared 2 Oct 2009

• LG1 Intelligent Medical Vigilance System

  Class II

  FDA 510(k) K052446 Active Cleared 2 Feb 2006

• Lifebed Network Patient Vigilance System

  Class II

  FDA 510(k) K083534 Active Cleared 13 Apr 2009

• Lifebed Patient Vigilance System

  Class II

  FDA 510(k) K082366 Active Cleared 26 Sep 2008

• What is the LifeBed Network Patient Vigilance System used for?

  The LifeBed Network Patient Vigilance System is a cardiac monitor that includes a cardiotachometer and rate alarm, designed to provide continuous patient monitoring in a networked healthcare environment, specifically intended for cardiovascular settings.

• How is the LifeBed Network Patient Vigilance System supplied?

  The system is supplied as a Class II medical device. The device data does not specify whether it is single-use or reusable, nor does it provide information about MRI safety.

• What is the regulatory status of the LifeBed Network Patient Vigilance System?

  The device is regulated under FDA 510(k) clearance with product code DRT and regulation number 870.2300. It was determined to be substantially equivalent to predicate devices and reviewed by the Cardiovascular advisory committee.

• What are the key specifications of the LifeBed Network Patient Vigilance System?

  The device is a cardiac monitoring system with cardiotachometer and rate alarm functionality. It is designed for networked healthcare environments and is classified as a Class II medical device. The device received FDA 510(k) clearance on April 15, 2010.