Cleared Traditional

HEINE GAMMA G7; HEINE GAMMA G5, HEINE GAMMA GP, HEINE GAMMA GST, HEINE GAMMA XXL LF MODEL M-000.09.23X, M-000.09.24X, M-

K101892 · Heine Optotechnik GmbH & Co. KG · Cardiovascular

Aug 2010

Decision

51d

Days

Class 2

Risk

About This 510(k) Submission

K101892 is an FDA 510(k) clearance for the HEINE GAMMA G7; HEINE GAMMA G5, HEINE GAMMA GP, HEINE GAMMA GST, HEINE GAMMA XXL LF MODEL M-000.09.23X, M-000.09.24X, M-, a Blood Pressure Cuff (Class II — Special Controls, product code DXQ), submitted by Heine Optotechnik GmbH & Co. KG (Hamburg, DE). The FDA issued a Cleared decision on August 27, 2010, 51 days after receiving the submission on July 7, 2010. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1120.

Submission Details

510(k) Number	K101892 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 07, 2010
Decision Date	August 27, 2010
Days to Decision	51 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.