T-SCOPE, TELEMETRIC PRECORDIAL STETHOSCOPE— 510(k) K894757

Name: FDA 510(k) clearance K894757
Creator: U.S. Food and Drug Administration
Published: 1989-09-18

Substantially Equivalent

Louisville Laboratories, Inc.

FDA 510(k) clearance K894757 for T-SCOPE, TELEMETRIC PRECORDIAL STETHOSCOPE, Substantially Equivalent on 1989-09-18. Applicant: Louisville Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Louisville Laboratories, Inc.
Product code: Code BZT
Device class: Class 2
Regulation: 21 CFR 868.1920
Advisory panel: Anesthesiology
Date received: 1989-07-27
Decision date: 1989-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Weston, MA, US

Download summary PDF View on FDA.gov ↗

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