AMBULO 2400 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM

System, Measurement, Blood-pressure, Non-invasive

MORTARA INSTRUMENT, INC.

The following data is part of a premarket notification filed by Mortara Instrument, Inc. with the FDA for Ambulo 2400 Ambulatory Blood Pressure Monitoring System.

Pre-market Notification Details

• Device ID: K133989
• 510k Number: K133989
• Device Name: AMBULO 2400 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM
• Classification: System, Measurement, Blood-pressure, Non-invasive
• Applicant: MORTARA INSTRUMENT, INC. 7865 NORTH 86TH ST. Milwaukee, WI 53224
• Contact: Amy Yang
• Correspondent: Amy Yang; MORTARA INSTRUMENT, INC. 7865 NORTH 86TH ST. Milwaukee, WI 53224
• Product Code: DXN
• CFR Regulation Number: 870.1130 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-12-26
• Decision Date: 2014-11-25
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00812345023350	K133989	000
00732094282610	K133989	000
00732094282603	K133989	000
00732094258776	K133989	000
00732094258769	K133989	000
00732094258752	K133989	000
00732094258462	K133989	000
00732094258448	K133989	000