Cleared Traditional

K962122 - SENTRY RADIOTRANSLUCENT ECG ELECTRODES
(FDA 510(k) Clearance)

K962122 · Sentry Medical Products, Inc. · Cardiovascular

Jul 1996

Decision

54d

Days

Class 2

Risk

K962122 is an FDA 510(k) clearance for the SENTRY RADIOTRANSLUCENT ECG ELECTRODES. This device is classified as a Electrode, Electrocardiograph (Class II — Special Controls, product code DRX).

Submitted by Sentry Medical Products, Inc. (Lombard, US). The FDA issued a Cleared decision on July 24, 1996, 54 days after receiving the submission on May 31, 1996.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2360.

Submission Details

510(k) Number	K962122 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 31, 1996
Decision Date	July 24, 1996
Days to Decision	54 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Statement