EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY

Device, Counter-pulsating, External

VASOMEDICAL, INC.

The following data is part of a premarket notification filed by Vasomedical, Inc. with the FDA for Eecp Therapy System Model Ts4 With/without Pluse Oximetry.

Pre-market Notification Details

• Device ID: K033617
• 510k Number: K033617
• Device Name: EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY
• Classification: Device, Counter-pulsating, External
• Applicant: VASOMEDICAL, INC. 180 LINDEN AVE. Westbury, NY 11590
• Contact: Thomas R Varricchione
• Correspondent: Thomas R Varricchione; VASOMEDICAL, INC. 180 LINDEN AVE. Westbury, NY 11590
• Product Code: DRN
• CFR Regulation Number: 870.5225 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-11-18
• Decision Date: 2004-03-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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