Series 1500 Defibrillator Modification

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

510(k) Number

K926172 ↗

FDA Product Code

MKJ

Device Class

Class III

Regulation

21 CFR Part 870.5310

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Alarm Display Unit/Pager-Lan System (Adu)

  Class II

  FDA 510(k) K962827 Active Cleared 24 Feb 1997

• Marquette 1200 Defibrillator

  Class III

  FDA 510(k) K882067 Active Cleared 17 Nov 1988

• Pulse Oximetry Module

  Class II

  FDA 510(k) K901071 Active Cleared 19 Jun 1990

• Smart Anesthesia Multi-Gas (Sam) Module

  Class II

  FDA 510(k) K943977 Active Cleared 23 Mar 1995

• Cardiosoft/Cardiosys

  Not classified

  FDA 510(k) K951130 Active Cleared 4 Apr 1996

• Silver Mactrode

  Class II

  FDA 510(k) K902176 Active Cleared 4 Sep 1990

See all devices from Marquette Electronics, Inc. →

• Is this defibrillator designed for single-use or can it be reused after maintenance?

  This Series 1500 Defibrillator Modification is explicitly described as a reusable medical device. It requires proper calibration and maintenance to ensure reliable performance, following standard protocols for defibrillator equipment in emergency settings.

• What types of cardiac emergencies is this defibrillator intended to treat, and where can it be used?

  The device is intended for treating ventricular fibrillation and pulseless ventricular tachycardia in patients experiencing sudden cardiac arrest. It is designed for emergency use in out-of-hospital and pre-hospital settings, such as ambulances or public locations where trained personnel respond to cardiac emergencies.

• How is this defibrillator regulated, and what does that mean for its use?

  This device is regulated under FDA 510(k) clearance (K926172) and is classified as Class III, requiring strict oversight. It is considered substantially equivalent to predicate devices and is intended for use by trained personnel in emergency response scenarios, ensuring compliance with regulatory standards for defibrillator safety and performance.

• Does this defibrillator require any special storage conditions, and how should it be handled?

  While the data does not specify exact storage conditions, standard protocols for defibrillator equipment apply. This includes proper calibration, maintenance, and handling to ensure reliability. Storage should follow best practices for medical devices in emergency settings, such as protection from extreme temperatures, moisture, and physical damage.