IP-SET

Electrode, Electrocardiograph

INTEGRAL PROCESS SAS

The following data is part of a premarket notification filed by Integral Process Sas with the FDA for Ip-set.

Pre-market Notification Details

• Device ID: K101685
• 510k Number: K101685
• Device Name: IP-SET
• Classification: Electrode, Electrocardiograph
• Applicant: INTEGRAL PROCESS SAS 12 RUE DES CAYENNES PB 310 Conflans Sainte Honorine, FR 78703
• Contact: Christian Berthon
• Correspondent: Tamas Borsai; TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470
• Product Code: DRX
• CFR Regulation Number: 870.2360 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2010-06-16
• Decision Date: 2010-07-01
• Summary: summary

NIH GUDID Devices

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