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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 the device name listed in this FDA 510(k) record. The listed applicant is Medical Graphics Corporation. It received FDA 510(k) clearance on 2019-04-12 under 510(k) 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. The listed applicant is Medical Graphics Corporation. The 510(k) number is K181912.

When did Ascent Cardiorespiratory Diagnostic Software receive FDA 510(k) clearance?

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

Who is the listed applicant for Ascent Cardiorespiratory Diagnostic Software?

The FDA 510(k) record lists Medical Graphics Corporation as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Medical Graphics Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242809Ascent Cardiorespiratory Diagnostic SoftwareK152585Resmon PRO FULL

Related Devices (Code: BTY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242809Ascent Cardiorespiratory Diagnostic SoftwareMedical Graphics CorporationK223629SpiroSphere, SpiroSphereECG, CardioSphereEresearchtechnology GmbHK231561Pulmonary Function Tester, Model: A9Guangzhou Homesun Medical Technology Co., Ltd.K222982Virtus Metabolic MonitorVirtus Technology ApsK221030Model 9100 PFT/DICOVitalograph Ireland, Ltd.K202754MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSUEresearchtechnology GmbH

Official Source

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

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