Cleared Traditional

EXACTA-SPEZIAL

K925295 · Rudolf Riester GmbH & Co. KG · Cardiovascular
Mar 1994
Decision
520d
Days
Class 2
Risk

About This 510(k) Submission

K925295 is an FDA 510(k) clearance for the EXACTA-SPEZIAL, a System, Measurement, Blood-pressure, Non-invasive (Class II — Special Controls, product code DXN), submitted by Rudolf Riester GmbH & Co. KG (D-72417 Jungingen, DE). The FDA issued a Cleared decision on March 25, 1994, 520 days after receiving the submission on October 21, 1992. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1130.

Submission Details

510(k) Number K925295 FDA.gov
FDA Decision Cleared SESE
Date Received October 21, 1992
Decision Date March 25, 1994
Days to Decision 520 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

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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