M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIEN

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

PHILIPS MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Philips Medical Systems, Inc. with the FDA for M3290a Intellivue Information Center Software Release F.0 And M4840a Philips Telemetry System Ii Including M4841a Patien.

Pre-market Notification Details

• Device ID: K041741
• 510k Number: K041741
• Device Name: M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIEN
• Classification: Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
• Applicant: PHILIPS MEDICAL SYSTEMS, INC. 3000 MINUTEMAN RD. Andover, MA 01810 -1099
• Contact: Barry Wyshogrod
• Correspondent: Barry Wyshogrod; PHILIPS MEDICAL SYSTEMS, INC. 3000 MINUTEMAN RD. Andover, MA 01810 -1099
• Product Code: MHX
• CFR Regulation Number: 870.1025 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-06-28
• Decision Date: 2004-07-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00884838011113	K041741	000
00884838011106	K041741	000
00884838011090	K041741	000