ELECTROCARDIOGRAPHIC ECG RECORDER— 510(k) K781152

Name: FDA 510(k) clearance K781152
Creator: U.S. Food and Drug Administration
Published: 1978-08-31

Substantially Equivalent

Cardio-Dynamics Laboratories, Inc.

FDA 510(k) clearance K781152 for ELECTROCARDIOGRAPHIC ECG RECORDER, Substantially Equivalent on 1978-08-31. Applicant: Cardio-Dynamics Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Cardio-Dynamics Laboratories, Inc.
Product code: Code DSM
Device class: Class 1
Regulation: 21 CFR 870.2640
Advisory panel: Cardiovascular
Date received: 1978-07-10
Decision date: 1978-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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