Cleared Traditional

VANTAGE ABI

K103693 · Summit Doppler Systems, Inc. · Cardiovascular
Feb 2011
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K103693 is an FDA 510(k) clearance for the VANTAGE ABI, a System, Measurement, Blood-pressure, Non-invasive (Class II — Special Controls, product code DXN), submitted by Summit Doppler Systems, Inc. (Golden, US). The FDA issued a Cleared decision on February 15, 2011, 60 days after receiving the submission on December 17, 2010. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1130.

Submission Details

510(k) Number K103693 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 2010
Decision Date February 15, 2011
Days to Decision 60 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXN — System, Measurement, Blood-pressure, Non-invasive
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1130

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