MONITORING SYSTEM,MODEL ARGUS PB-1000

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

SCHILLER AG

The following data is part of a premarket notification filed by Schiller Ag with the FDA for Monitoring System,model Argus Pb-1000.

Pre-market Notification Details

• Device ID: K012226
• 510k Number: K012226
• Device Name: MONITORING SYSTEM,MODEL ARGUS PB-1000
• Classification: Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
• Applicant: SCHILLER AG ALTGASSE 68 Baar, CH Ch-6341
• Contact: Markus Buetler
• Correspondent: Markus Buetler; SCHILLER AG ALTGASSE 68 Baar, CH Ch-6341
• Product Code: MHX
• CFR Regulation Number: 870.1025 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-07-16
• Decision Date: 2002-04-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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