ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE

Electrode, Electrocardiograph

BIO PROTECH, INC.

The following data is part of a premarket notification filed by Bio Protech, Inc. with the FDA for Electrocardiograph (ecg) Electrode, Non-sterile.

Pre-market Notification Details

• Device ID: K020003
• 510k Number: K020003
• Device Name: ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE
• Classification: Electrode, Electrocardiograph
• Applicant: BIO PROTECH, INC. 198 AVENUE DE LA D'EMERALD Sparks, NV 89434 -9550
• Contact: Janna P Tucker
• Correspondent: Janna P Tucker; BIO PROTECH, INC. 198 AVENUE DE LA D'EMERALD Sparks, NV 89434 -9550
• Product Code: DRX
• CFR Regulation Number: 870.2360 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-01-02
• Decision Date: 2002-11-07
• Summary: summary

NIH GUDID Devices

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