DATEX-OHMEDA S/5 PSM MODULE, (CONSISTING OF E-PSM AND E-PSMP MODULES) 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 S/5 Psm Module, (consisting Of E-psm And E-psmp Modules) And Accessories.

Pre-market Notification Details

• Device ID: K043551
• 510k Number: K043551
• Device Name: DATEX-OHMEDA S/5 PSM MODULE, (CONSISTING OF E-PSM AND E-PSMP MODULES) 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: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-12-23
• Decision Date: 2005-02-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840682120104	K043551	000
00840682120098	K043551	000
00840682119832	K043551	000
00840682104081	K043551	000
00840682103435	K043551	000
00840682103428	K043551	000
00840682103152	K043551	000
00840682103138	K043551	000