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FDA 510(k)

VITALOGRAPH DATA STORAGE SPIROMETER

K-Number: K930085 · 1993-07-26

ApplicantVitalograph , Ltd.
Decision Date1993-07-26
Product CodeBTY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VITALOGRAPH DATA STORAGE SPIROMETER is the device name listed in this FDA 510(k) record. The listed applicant is Vitalograph , Ltd.. It received FDA 510(k) clearance on 1993-07-26 under 510(k) number K930085. 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 VITALOGRAPH DATA STORAGE SPIROMETER?

VITALOGRAPH DATA STORAGE SPIROMETER is a medical device that received FDA 510(k) clearance on 1993-07-26. The listed applicant is Vitalograph , Ltd.. The 510(k) number is K930085.

When did VITALOGRAPH DATA STORAGE SPIROMETER receive FDA 510(k) clearance?

VITALOGRAPH DATA STORAGE SPIROMETER received FDA 510(k) clearance on 1993-07-26, under 510(k) number K930085.

Who is the listed applicant for VITALOGRAPH DATA STORAGE SPIROMETER?

The FDA 510(k) record lists Vitalograph , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITALOGRAPH DATA STORAGE SPIROMETER?

The FDA product code for VITALOGRAPH DATA STORAGE SPIROMETER 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 Vitalograph , Ltd. 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.

K253293VitaloJAK Clinic (Model 7100)K950854VITALOGRAPH 2110 SOFTWARE INTERFACEK925085ESCORT SPIROMETERK912412VITALOGRAPH SPIROTRAC IIIK893665AEROSOL INHALATION MONITORK892524VITALOGRAPH-BREATHCO MONITOR

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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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