Cleared Traditional

PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20

K053011 · Bio Protech, Inc. · Cardiovascular
Dec 2005
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K053011 is an FDA 510(k) clearance for the PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20, a Electrode, Electrocardiograph (Class II — Special Controls, product code DRX), submitted by Bio Protech, Inc. (Crofton, US). The FDA issued a Cleared decision on December 14, 2005, 49 days after receiving the submission on October 26, 2005. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2360.

Submission Details

510(k) Number K053011 FDA.gov
FDA Decision Cleared SESE
Date Received October 26, 2005
Decision Date December 14, 2005
Days to Decision 49 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DRX — Electrode, Electrocardiograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2360

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