INFINITY DELTA/DELTA XL/ KAPPA/ GAMMA X XL/ VISTA XL/ SC7000/SC8000/ SC9000XL

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 Delta/delta Xl/ Kappa/ Gamma X Xl/ Vista Xl/ Sc7000/sc8000/ Sc9000xl.

Pre-market Notification Details

• Device ID: K070566
• 510k Number: K070566
• Device Name: INFINITY DELTA/DELTA XL/ KAPPA/ GAMMA X XL/ VISTA XL/ SC7000/SC8000/ SC9000XL
• Classification: Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
• Applicant: Draeger Medical Systems, Inc. 6 TECH DRIVE Andover, MA 01810
• Contact: Mark Kieras
• Correspondent: Mark Kieras; 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: 2007-02-28
• Decision Date: 2007-06-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04049098006248	K070566	000
04049098005494	K070566	000
04049098005487	K070566	000
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