Who is the manufacturer of PORTABLE INSTENSIVE CARE UNIT?

Medical Research Laboratories, Inc. submitted the Special clearance for PORTABLE INSTENSIVE CARE UNIT (K010207).

What is the FDA product code for PORTABLE INSTENSIVE CARE UNIT?

MKJ. It is classified under 21 CFR 870.5310 as a Class 3 device in the Cardiovascular panel.

What is the regulatory pathway for PORTABLE INSTENSIVE CARE UNIT?

510(k) clearance (submission type: Special).

PORTABLE INSTENSIVE CARE UNIT

K010207 · Medical Research Laboratories, Inc. · MKJ · Jun 14, 2001 · Cardiovascular

Device Facts

Record ID	K010207
Device Name	PORTABLE INSTENSIVE CARE UNIT
Applicant	Medical Research Laboratories, Inc.
Product Code	MKJ · Cardiovascular
Decision Date	Jun 14, 2001
Decision	ST
Submission Type	Special
Regulation	21 CFR 870.5310
Device Class	Class 3

Regulatory Classification

Identification

An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.