VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100

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

CRITICARE SYSTEMS, INC.

The following data is part of a premarket notification filed by Criticare Systems, Inc. with the FDA for Vital Signs Monitor W/arrhythmia Detection And St Analysis, Model 8100.

Pre-market Notification Details

• Device ID: K030613
• 510k Number: K030613
• Device Name: VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100
• Classification: Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
• Applicant: CRITICARE SYSTEMS, INC. 20925 CROSSROADS CIRCLE Waukesha, WI 53186
• Contact: Alex Kaplan
• Correspondent: Alex Kaplan; CRITICARE SYSTEMS, INC. 20925 CROSSROADS CIRCLE Waukesha, WI 53186
• Product Code: MHX
• CFR Regulation Number: 870.1025 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-02-26
• Decision Date: 2003-04-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B4388100EUS0	K030613	000
B4388100EPUS0	K030613	000
B4388100EPST0	K030613	000
B4388100EP1US0	K030613	000
B4388100EP1ST0	K030613	000
B4388100E1US0	K030613	000
B4388100E1ST0	K030613	000