CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box

Computer, Blood-pressure

VOLCANO CORPORATION

The following data is part of a premarket notification filed by Volcano Corporation with the FDA for Core Fm System, Patient Interface Module (opim), Hemodynamic Converter Box.

Pre-market Notification Details

• Device ID: K152582
• 510k Number: K152582
• Device Name: CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box
• Classification: Computer, Blood-pressure
• Applicant: VOLCANO CORPORATION 3721 VALLEY CENTRE DR STE 500 San Diego, CA 92130
• Contact: Nathan Da Silva
• Correspondent: Nathan Da Silva; VOLCANO CORPORATION 3721 VALLEY CENTRE DR STE 500 San Diego, CA 92130
• Product Code: DSK
• CFR Regulation Number: 870.1110 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-09-10
• Decision Date: 2015-12-03

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00845255012657	K152582	000
00845225012496	K152582	000
00845225012489	K152582	000
00845225012472	K152582	000
00845225012656	K152582	000