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FDA 510(k)

MODIFICATION TO THE OXYCONALPHA

K-Number: K980094 · 1998-07-28

ApplicantErich Jaeger B.V.
Decision Date1998-07-28
Product CodeBTY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO THE OXYCONALPHA is the device name listed in this FDA 510(k) record. The listed applicant is Erich Jaeger B.V.. It received FDA 510(k) clearance on 1998-07-28 under 510(k) number K980094. 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 MODIFICATION TO THE OXYCONALPHA?

MODIFICATION TO THE OXYCONALPHA is a medical device that received FDA 510(k) clearance on 1998-07-28. The listed applicant is Erich Jaeger B.V.. The 510(k) number is K980094.

When did MODIFICATION TO THE OXYCONALPHA receive FDA 510(k) clearance?

MODIFICATION TO THE OXYCONALPHA received FDA 510(k) clearance on 1998-07-28, under 510(k) number K980094.

Who is the listed applicant for MODIFICATION TO THE OXYCONALPHA?

The FDA 510(k) record lists Erich Jaeger B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO THE OXYCONALPHA?

The FDA product code for MODIFICATION TO THE OXYCONALPHA is BTY.

Related Clinical Trials

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Other records listing Erich Jaeger B.V. 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.

K992214OXYCON PROK984465OXYCONALPHA WITH OPTION ECG

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.

K260242CPETWise PlatformMedibyt , Ltd.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.

Official Source

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