Cleared Traditional

SANAPHON N

K972378 · Rudolf Riester GmbH & Co. KG · Cardiovascular
Sep 1997
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K972378 is an FDA 510(k) clearance for the SANAPHON N, a Blood Pressure Cuff (Class II — Special Controls, product code DXQ), submitted by Rudolf Riester GmbH & Co. KG (Jungingen, DE). The FDA issued a Cleared decision on September 24, 1997, 90 days after receiving the submission on June 26, 1997. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1120.

Submission Details

510(k) Number K972378 FDA.gov
FDA Decision Cleared SESE
Date Received June 26, 1997
Decision Date September 24, 1997
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code DXQ — Blood Pressure Cuff
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1120
Definition A Blood Pressure Cuff Is A Device That Has An Inflatable Bladder In An Elastic Sleeve (cuff) With A Mechanism For Inflating The Bladder. The Cuff Is Used To Determine A Subject's Blood Pressure.

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