Cleared Traditional

IP-SET

K101685 · Integral Process Sas · Cardiovascular

Jul 2010

Decision

15d

Days

Class 2

Risk

About This 510(k) Submission

K101685 is an FDA 510(k) clearance for the IP-SET, a Electrode, Electrocardiograph (Class II — Special Controls, product code DRX), submitted by Integral Process Sas (Conflans Sainte Honorine, FR). The FDA issued a Cleared decision on July 1, 2010, 15 days after receiving the submission on June 16, 2010. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2360.

Submission Details

510(k) Number	K101685 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 16, 2010
Decision Date	July 01, 2010
Days to Decision	15 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF