MAGLIFE

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

ODAM

The following data is part of a premarket notification filed by Odam with the FDA for Maglife.

Pre-market Notification Details

• Device ID: K950264
• 510k Number: K950264
• Device Name: MAGLIFE
• Classification: Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
• Applicant: ODAM 49 PLAIN ST. NORTH ATTLEBORO, MA 02760
• Contact: STEVEN CLARKE
• Correspondent: STEVEN CLARKE; ODAM 49 PLAIN ST. NORTH ATTLEBORO, MA 02760
• Product Code: MHX
• CFR Regulation Number: 870.1025 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-01-23
• Decision Date: 1996-09-27