360 SLX Advisory Defibrillator

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

510(k) Number

K935922 ↗

FDA Product Code

MKJ

Device Class

Class III

Regulation

21 CFR Part 870.5310

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Porta Pak 90

  Class II

  FDA 510(k) K840900 Active Cleared 11 Jun 1984

• Dpd Defibrillator

  Class II

  FDA 510(k) K952085 Active Cleared 5 Jun 1995

• Porta Pulse III #D320

  Class II

  FDA 510(k) K833751 Active Cleared 11 Jan 1984

• Portable Intensive Care Unit Modification

  Class III

  FDA 510(k) K983307 Active Cleared 20 Nov 1998

• Mrl Blood Pressure Monitor

  Class II

  FDA 510(k) K885191 Active Cleared 23 May 1989

• 450SLL Defibrillator

  Class II

  FDA 510(k) K874204 Active Cleared 28 Jan 1988

See all devices from Medical Research Laboratories, Inc. →

• What types of settings is the 360 SLX Advisory Defibrillator designed for, and who can use it?

  The 360 SLX Advisory Defibrillator is specifically designed for pre-hospital, clinical, and public-access environments where cardiac emergencies may occur. It is intended for use by trained personnel, such as emergency medical responders, healthcare professionals, or even lay responders in public settings, who may need to administer defibrillation during sudden cardiac arrest situations.

• Is the 360 SLX Advisory Defibrillator a single-use or reusable device, and what maintenance is required?

  The 360 SLX Advisory Defibrillator is a reusable medical device. Since it is not single-use, it requires proper maintenance and regular calibration to ensure reliable performance and safety. This includes routine checks, cleaning, and servicing as recommended by the manufacturer to maintain its functionality over time.

• How does the 360 SLX Advisory Defibrillator assist operators during an emergency?

  The 360 SLX Advisory Defibrillator provides real-time analysis of heart rhythms and offers advisory guidance to operators. It determines whether defibrillation is required and advises the user accordingly, helping to ensure timely and appropriate intervention during sudden cardiac arrest situations.

• What regulatory pathway was followed for the approval of the 360 SLX Advisory Defibrillator?

  The 360 SLX Advisory Defibrillator was cleared through the FDA’s 510(k) pathway, specifically under a traditional review process. It was determined to be substantially equivalent to a legally marketed predicate device and falls under the Class III classification for defibrillators, adhering to strict manufacturing and safety standards.

• What is the primary purpose of the 360 SLX Advisory Defibrillator, and how does it differ from other defibrillators?

  The primary purpose of the 360 SLX Advisory Defibrillator is to deliver electrical shocks to restore a normal heart rhythm in patients experiencing sudden cardiac arrest. Unlike some defibrillators that may require manual analysis of rhythms, this device provides real-time advisory analysis, guiding operators on whether defibrillation is needed, which can be particularly useful in emergency situations where quick decision-making is critical.