Cleared Traditional

RI-SAN/RI-SANA BLOOD PRESSURE MANOMETERS

K002954 · Rudolf Riester GmbH & Co. KG · Cardiovascular

Dec 2000

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K002954 is an FDA 510(k) clearance for the RI-SAN/RI-SANA BLOOD PRESSURE MANOMETERS, 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 December 21, 2000, 90 days after receiving the submission on September 22, 2000. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1120.

Submission Details

510(k) Number	K002954 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 22, 2000
Decision Date	December 21, 2000
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

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.