Cleared Traditional

Ascent Cardiorespiratory Diagnostic Software

K242809 · Medical Graphics Corporation · Anesthesiology

Oct 2024

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K242809 is an FDA 510(k) clearance for the Ascent Cardiorespiratory Diagnostic Software, a Calculator, Predicted Values, Pulmonary Function (Class II — Special Controls, product code BTY), submitted by Medical Graphics Corporation (Saint Paul, US). The FDA issued a Cleared decision on October 17, 2024, 30 days after receiving the submission on September 17, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1890.

Submission Details

510(k) Number	K242809 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 17, 2024
Decision Date	October 17, 2024
Days to Decision	30 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF