INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM

Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

Draeger Medical Systems, Inc.

The following data is part of a premarket notification filed by Draeger Medical Systems, Inc. with the FDA for Infinity Multiview Infinity Telemetry System.

Pre-market Notification Details

• Device ID: K060223
• 510k Number: K060223
• Device Name: INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM
• Classification: Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
• Applicant: Draeger Medical Systems, Inc. 16 ELECTRONICS AVE. Danvers, MA 01923
• Contact: Karen A Iorio
• Correspondent: Karen A Iorio; Draeger Medical Systems, Inc. 16 ELECTRONICS AVE. Danvers, MA 01923
• Product Code: MHX
• CFR Regulation Number: 870.1025 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-01-30
• Decision Date: 2006-04-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04049098005067	K060223	000