DATEX-OHMEDA PRESTN MODULE, (MODEL FAMILY M-PRESTN) AND ACCESSORIES

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

DATEX-OHMEDA

The following data is part of a premarket notification filed by Datex-ohmeda with the FDA for Datex-ohmeda Prestn Module, (model Family M-prestn) And Accessories.

Pre-market Notification Details

• Device ID: K031781
• 510k Number: K031781
• Device Name: DATEX-OHMEDA PRESTN MODULE, (MODEL FAMILY M-PRESTN) AND ACCESSORIES
• Classification: Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
• Applicant: DATEX-OHMEDA 86 PILGRIM RD. Needham, MA 02492
• Contact: Joel Kent
• Correspondent: Joel Kent; DATEX-OHMEDA 86 PILGRIM RD. 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: 2003-06-10
• Decision Date: 2003-06-25
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840682103381	K031781	000
00840682103190	K031781	000