CARDIAX

Electrocardiograph

FAIRLAKE MARKETING GROUP, INC.

The following data is part of a premarket notification filed by Fairlake Marketing Group, Inc. with the FDA for Cardiax.

Pre-market Notification Details

• Device ID: K924544
• 510k Number: K924544
• Device Name: CARDIAX
• Classification: Electrocardiograph
• Applicant: FAIRLAKE MARKETING GROUP, INC. 1223 FAIRLAKE TRACE, SUITE 802 Ft. Lauderdale, FL 33326
• Contact: Steven W Gargano
• Correspondent: Steven W Gargano; FAIRLAKE MARKETING GROUP, INC. 1223 FAIRLAKE TRACE, SUITE 802 Ft. Lauderdale, FL 33326
• Product Code: DPS
• CFR Regulation Number: 870.2340 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-09-08
• Decision Date: 1993-07-29