INFINITY MONITORS WITH SCIO MODIFICATIONS

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 Monitors With Scio Modifications.

Pre-market Notification Details

• Device ID: K051628
• 510k Number: K051628
• Device Name: INFINITY MONITORS WITH SCIO MODIFICATIONS
• Classification: Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
• Applicant: Draeger Medical Systems, Inc. 16 ELECTRONICS AVE. Danvers, MA 01923
• Contact: Penelope H Greco
• Correspondent: Penelope H Greco; 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: 2005-06-20
• Decision Date: 2005-07-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04048675429333	K051628	000
04048675429326	K051628	000
04048675429319	K051628	000
04048675429302	K051628	000