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FDA 510(k)

PEDS PULMONARY EVALUATION & DIAGNOSTIC SYSTEM

K-Number: K864087 · 1986-11-07

ApplicantMedical Associated Services, Inc.
Decision Date1986-11-07
Product CodeBTY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PEDS PULMONARY EVALUATION & DIAGNOSTIC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medical Associated Services, Inc.. It received FDA 510(k) clearance on 1986-11-07 under 510(k) number K864087. 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 PEDS PULMONARY EVALUATION & DIAGNOSTIC SYSTEM?

PEDS PULMONARY EVALUATION & DIAGNOSTIC SYSTEM is a medical device that received FDA 510(k) clearance on 1986-11-07. The listed applicant is Medical Associated Services, Inc.. The 510(k) number is K864087.

When did PEDS PULMONARY EVALUATION & DIAGNOSTIC SYSTEM receive FDA 510(k) clearance?

PEDS PULMONARY EVALUATION & DIAGNOSTIC SYSTEM received FDA 510(k) clearance on 1986-11-07, under 510(k) number K864087.

Who is the listed applicant for PEDS PULMONARY EVALUATION & DIAGNOSTIC SYSTEM?

The FDA 510(k) record lists Medical Associated Services, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PEDS PULMONARY EVALUATION & DIAGNOSTIC SYSTEM?

The FDA product code for PEDS PULMONARY EVALUATION & DIAGNOSTIC 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.

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 Medical Associated Services, Inc. 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.

K921178PTI-A, PTI-P, PTI-N DISPOSABLE PNEUMOTACHSK903939PANDA HELIUM GAS ANALYZERK893845PEDS WATER FILLED CATHETER/TRANSDUCER SYSTEMK883008PULMONARY FORCED FLOW SYSTEM (PUFFS)K881122UPDATED MANUAL FOR PEDS - PULMONARY EVAL. & DIAG.

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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