PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE

Computer, Diagnostic, Pre-programmed, Single-function

PULSION MEDICAL SYSTEMS SE

The following data is part of a premarket notification filed by Pulsion Medical Systems Se with the FDA for Pulsioflex Monitoring System With Picco Module.

Pre-market Notification Details

• Device ID: K122121
• 510k Number: K122121
• Device Name: PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE
• Classification: Computer, Diagnostic, Pre-programmed, Single-function
• Applicant: PULSION MEDICAL SYSTEMS SE 1511 ESSEX RD Westbrook, CT 06498
• Contact: Jamie Sulley
• Correspondent: Jamie Sulley; PULSION MEDICAL SYSTEMS SE 1511 ESSEX RD Westbrook, CT 06498
• Product Code: DXG
• CFR Regulation Number: 870.1435 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-07-17
• Decision Date: 2012-08-02

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04250094501525	K122121	000
04250094501402	K122121	000