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FDA 510(k)

Ascent Cardiorespiratory Diagnostic Software

K-Number: K181912 · 2019-04-12

ApplicantMedical Graphics Corporation
Decision Date2019-04-12
Product CodeBTY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Ascent Cardiorespiratory Diagnostic Software is a medical device manufactured by Medical Graphics Corporation. It received FDA 510(k) clearance on 2019-04-12 under approval number K181912. The device is classified under product code BTY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ascent Cardiorespiratory Diagnostic Software?

Ascent Cardiorespiratory Diagnostic Software is a medical device that received FDA 510(k) clearance on 2019-04-12. It is manufactured by Medical Graphics Corporation. The 510(k) number is K181912.

When was Ascent Cardiorespiratory Diagnostic Software approved by the FDA?

Ascent Cardiorespiratory Diagnostic Software received FDA 510(k) clearance on 2019-04-12, under approval number K181912.

What company makes Ascent Cardiorespiratory Diagnostic Software?

Ascent Cardiorespiratory Diagnostic Software is manufactured by Medical Graphics Corporation.

What is the FDA product code for Ascent Cardiorespiratory Diagnostic Software?

The FDA product code for Ascent Cardiorespiratory Diagnostic Software is BTY.

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Related PubMed Literature

PMID: 41513582 Medical devices for professional use: What assessment, what funding? Therapie (2026) PMID: 40643665 [Regulatory classification of AI-enabled products for medical use on the basis of the EU AI Act and MDR/IVDR]. Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz (2025)

Other Devices by Medical Graphics Corporation

K242809Ascent Cardiorespiratory Diagnostic Software

Related Devices (Code: BTY)

K150888Shape-HF Cardiopulmonary Testing SystemShape Medical Systems, Inc. K161534EasyOne Pro Respiratory Analysis SystemNdd Medizintechnik AG K173937SpiroSphereEresearchtechnology GmbH K190800Cosmed Q-NRG / Q-NRG+ Portable Metabolic MonitorsCosmed Srl K202754MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSUEresearchtechnology GmbH K221030Model 9100 PFT/DICOVitalograph Ireland, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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