Cleared Traditional

K911935 - CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED
(FDA 510(k) Clearance)

K911935 · Gould, Inc. · Cardiovascular

Jul 1991

Decision

82d

Days

Class 2

Risk

K911935 is an FDA 510(k) clearance for the CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED. This device is classified as a Amplifier And Signal Conditioner, Biopotential (Class II — Special Controls, product code DRR).

Submitted by Gould, Inc. (Valley View, US). The FDA issued a Cleared decision on July 22, 1991, 82 days after receiving the submission on May 1, 1991.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2050.

Submission Details

510(k) Number	K911935 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 01, 1991
Decision Date	July 22, 1991
Days to Decision	82 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Statement