Cleared Special

BRAUN PRECISION SENSOR PRO, MODEL BP 2590

K012035 · Braun GmbH · Cardiovascular
Jul 2001
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K012035 is an FDA 510(k) clearance for the BRAUN PRECISION SENSOR PRO, MODEL BP 2590, 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 July 27, 2001, 28 days after receiving the submission on June 29, 2001. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1130.

Submission Details

510(k) Number K012035 FDA.gov
FDA Decision Cleared SESE
Date Received June 29, 2001
Decision Date July 27, 2001
Days to Decision 28 days
Submission Type Special
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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