Cleared Special

MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A

K071058 · Nihon Kohden America, Inc. · Cardiovascular

Jun 2007

Decision

74d

Days

Class 2

Risk

About This 510(k) Submission

K071058 is an FDA 510(k) clearance for the MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A, a Transmitters And Receivers, Physiological Signal, Radiofrequency (Class II — Special Controls, product code DRG), submitted by Nihon Kohden America, Inc. (Foothill Ranch, US). The FDA issued a Cleared decision on June 29, 2007, 74 days after receiving the submission on April 16, 2007. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2910.

Submission Details

510(k) Number	K071058 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 16, 2007
Decision Date	June 29, 2007
Days to Decision	74 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	DRG — Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.2910