Ascent Cardiorespiratory Diagnostic Software— 510(k) K181912

Name: FDA 510(k) clearance K181912
Creator: U.S. Food and Drug Administration
Published: 2019-04-12

Substantially Equivalent

Medical Graphics Corporation

FDA 510(k) clearance K181912 for Ascent Cardiorespiratory Diagnostic Software, Substantially Equivalent on 2019-04-12. Applicant: Medical Graphics Corporation. Device class: 2.

Clearance details

Applicant: Medical Graphics Corporation
Product code: Code BTY
Device class: Class 2
Regulation: 21 CFR 868.1890
Advisory panel: Anesthesiology
Date received: 2018-07-17
Decision date: 2019-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

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