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FDA 510(k)

EASYONE PRO RESPIRATORY ANALYSIS SYSTEM

K-Number: K091428 · 2010-01-27

ApplicantNdd Medizitechnik AG
Decision Date2010-01-27
Product CodeBTY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EASYONE PRO RESPIRATORY ANALYSIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ndd Medizitechnik AG. It received FDA 510(k) clearance on 2010-01-27 under 510(k) number K091428. 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 EASYONE PRO RESPIRATORY ANALYSIS SYSTEM?

EASYONE PRO RESPIRATORY ANALYSIS SYSTEM is a medical device that received FDA 510(k) clearance on 2010-01-27. The listed applicant is Ndd Medizitechnik AG. The 510(k) number is K091428.

When did EASYONE PRO RESPIRATORY ANALYSIS SYSTEM receive FDA 510(k) clearance?

EASYONE PRO RESPIRATORY ANALYSIS SYSTEM received FDA 510(k) clearance on 2010-01-27, under 510(k) number K091428.

Who is the listed applicant for EASYONE PRO RESPIRATORY ANALYSIS SYSTEM?

The FDA 510(k) record lists Ndd Medizitechnik AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EASYONE PRO RESPIRATORY ANALYSIS SYSTEM?

The FDA product code for EASYONE PRO RESPIRATORY ANALYSIS SYSTEM is BTY.

Related Clinical Trials

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.

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Other records listing Ndd Medizitechnik AG 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.

K120635EASYONE PRO RESPIRATORY TESTING DEVICEK090034EASY ON-PC SPIROMETER

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

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