Marquette 1200 Defibrillator

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

510(k) Number

K882067 ↗

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

• 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

• Cd Telemetry Systems

  Class II

  FDA 510(k) K891104 Active Cleared 19 Apr 1989

See all devices from Marquette Electronics, Inc. →

• Is the Marquette 1200 Defibrillator intended for single-use or can it be reused in clinical settings?

  The Marquette 1200 Defibrillator is designed as a reusable unit, not for single-use. Since it is classified as a Class III device for emergency cardiac resuscitation, it requires proper maintenance, calibration, and servicing to ensure reliable performance over repeated use in pre-hospital or clinical settings.

• What types of settings is the Marquette 1200 Defibrillator authorized for use in, and who can operate it?

  The device is authorized for use in pre-hospital and clinical settings, such as emergency rooms or ambulance services. It is intended for trained personnel, including emergency medical technicians (EMTs) and healthcare providers, who have received proper training in cardiac resuscitation and defibrillation protocols.

• How is the Marquette 1200 Defibrillator regulated in the U.S., and what does its classification mean for purchasing or deployment?

  The Marquette 1200 Defibrillator is classified as a Class III medical device under FDA regulations, requiring pre-market approval due to its critical role in emergency cardiac care. It was granted FDA 510(k) clearance (K882067) under the *substantially equivalent* determination, meaning it meets regulatory standards for safety and effectiveness compared to a predicate device. Purchasers should confirm compliance with FDA regulations (e.g., 21 CFR 870.5310) and ensure proper maintenance protocols are followed.

• Does the Marquette 1200 Defibrillator require any special storage conditions, and is it shipped sterile?

  The device is not described as sterile in its specifications, so it is not intended for single-patient use without additional sterilization procedures. Since it is reusable, it should be stored in a clean, dry environment to prevent damage or contamination. Proper maintenance and calibration are critical before and after each use to ensure functionality.