INFINITY CENTRALSTATION WITH INFINITY M300

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 Centralstation With Infinity M300.

Pre-market Notification Details

• Device ID: K130711
• 510k Number: K130711
• Device Name: INFINITY CENTRALSTATION WITH INFINITY M300
• Classification: Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
• Applicant: Draeger Medical Systems, Inc. 6 TECH DRIVE Andover, MA 01810
• Contact: Tom Ostrowski
• Correspondent: Tom Ostrowski; Draeger Medical Systems, Inc. 6 TECH DRIVE Andover, MA 01810
• Product Code: MHX
• CFR Regulation Number: 870.1025 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-03-15
• Decision Date: 2013-04-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04049098050104	K130711	000
04049098049405	K130711	000
04049098049023	K130711	000
04049098048989	K130711	000
04049098004183	K130711	000
04049098002066	K130711	000
04049098002035	K130711	000
04049098001878	K130711	000