CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED— 510(k) K911935

Name: FDA 510(k) clearance K911935
Creator: U.S. Food and Drug Administration
Published: 1991-07-22

Substantially Equivalent

Gould, Inc.

FDA 510(k) clearance K911935 for CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED, Substantially Equivalent on 1991-07-22. Applicant: Gould, Inc.. Device class: 2.

Clearance details

Applicant: Gould, Inc.
Product code: Code DRR
Device class: Class 2
Regulation: 21 CFR 870.2050
Advisory panel: Cardiovascular
Date received: 1991-05-01
Decision date: 1991-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Valley View, OH, US

Download summary PDF View on FDA.gov ↗

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