AWARE

Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

AMBIENT CLINICAL ANALYTICS

The following data is part of a premarket notification filed by Ambient Clinical Analytics with the FDA for Aware.

Pre-market Notification Details

• Device ID: K143372
• 510k Number: K143372
• Device Name: AWARE
• Classification: Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
• Applicant: AMBIENT CLINICAL ANALYTICS 221 1ST AVENUE SOUTHWEST Rochester, NY 55902
• Contact: Allen Berning
• Correspondent: Mark Job; REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114
• Product Code: MWI
• CFR Regulation Number: 870.2300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2014-11-25
• Decision Date: 2015-04-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850893007033	K143372	000
00850893007026	K143372	000
00850893007019	K143372	000
00850893007002	K143372	000