STOCKERT S3 ROLLER PUMP MODULE STOCKERT S3 CONSOLE

• K Number: K950990
• Device Name: STOCKERT S3 ROLLER PUMP MODULE STOCKERT S3 CONSOLE
• Manufacturer: STOECKERT INSTRUMENTE
• Date Cleared: 1996-01-19 ( 322 days)
• Product Code: DTQ
• Regulation Number: 870.4220
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: N/A

Intended Use

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Device Description

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AI/ML Overview

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Regulation Number and Section

§ 870.4220 Cardiopulmonary bypass heart-lung machine console.

(a)
Identification. A cardiopulmonary bypass heart-lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger.(b)
Classification. Class II (performance standards).