DATEX-OHMEDA PRESTIN MODULE (MODEL FAMILY E-PRESTIN, INCLUDING E-PRESTIN, E-RESTIN, E=PRETIN, E-PP AND E-PT/E-P)

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

GE HEALTHCARE

The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Datex-ohmeda Prestin Module (model Family E-prestin, Including E-prestin, E-restin, E=pretin, E-pp And E-pt/e-p).

Pre-market Notification Details

• Device ID: K051217
• 510k Number: K051217
• Device Name: DATEX-OHMEDA PRESTIN MODULE (MODEL FAMILY E-PRESTIN, INCLUDING E-PRESTIN, E-RESTIN, E=PRETIN, E-PP AND E-PT/E-P)
• Classification: Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
• Applicant: GE HEALTHCARE 86 PILGRIM ROAD Needham, MA 02492
• Contact: Joel Kent
• Correspondent: Joel Kent; GE HEALTHCARE 86 PILGRIM ROAD Needham, MA 02492
• Product Code: MHX
• CFR Regulation Number: 870.1025 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-05-12
• Decision Date: 2006-02-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840682104159	K051217	000
00840682104128	K051217	000