Cleared Traditional

BRAUN PRECISION SENSOR, MODEL BP 2000 SERIES

K003732 · Braun GmbH · Cardiovascular
May 2001
Decision
163d
Days
Class 2
Risk

About This 510(k) Submission

K003732 is an FDA 510(k) clearance for the BRAUN PRECISION SENSOR, MODEL BP 2000 SERIES, a System, Measurement, Blood-pressure, Non-invasive (Class II — Special Controls, product code DXN), submitted by Braun GmbH (Carlsbad, US). The FDA issued a Cleared decision on May 16, 2001, 163 days after receiving the submission on December 4, 2000. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1130.

Submission Details

510(k) Number K003732 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 2000
Decision Date May 16, 2001
Days to Decision 163 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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