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FDA 510(k)

EASYONE PRO RESPIRATORY TESTING DEVICE

K-Number: K120635 · 2012-09-27

ApplicantNdd Medizitechnik AG
Decision Date2012-09-27
Product CodeBTY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EASYONE PRO RESPIRATORY TESTING DEVICE 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 2012-09-27 under 510(k) number K120635. 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 TESTING DEVICE?

EASYONE PRO RESPIRATORY TESTING DEVICE is a medical device that received FDA 510(k) clearance on 2012-09-27. The listed applicant is Ndd Medizitechnik AG. The 510(k) number is K120635.

When did EASYONE PRO RESPIRATORY TESTING DEVICE receive FDA 510(k) clearance?

EASYONE PRO RESPIRATORY TESTING DEVICE received FDA 510(k) clearance on 2012-09-27, under 510(k) number K120635.

Who is the listed applicant for EASYONE PRO RESPIRATORY TESTING DEVICE?

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 TESTING DEVICE?

The FDA product code for EASYONE PRO RESPIRATORY TESTING DEVICE 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K091428EASYONE PRO RESPIRATORY ANALYSIS SYSTEMK090034EASY 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

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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