Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth— 510(k) K182196

Name: FDA 510(k) clearance K182196
Creator: U.S. Food and Drug Administration
Published: 2018-09-11

Substantially Equivalent

Imediplus, Inc.

FDA 510(k) clearance K182196 for Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth, Substantially Equivalent on 2018-09-11. Applicant: Imediplus, Inc.. Device class: 2.

Clearance details

Applicant: Imediplus, Inc.
Product code: Code DQD
Device class: Class 2
Regulation: 21 CFR 870.1875
Advisory panel: Cardiovascular
Date received: 2018-08-14
Decision date: 2018-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chupei City, TW

Download summary PDF View on FDA.gov ↗

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