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FDA 510(k)

CUSTO VIT PULMONARY FUNCTION ANALYSIS SYSTEM

K-Number: K854745 · 1986-01-10

ApplicantVersacor, Inc.
Decision Date1986-01-10
Product CodeBTY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CUSTO VIT PULMONARY FUNCTION ANALYSIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Versacor, Inc.. It received FDA 510(k) clearance on 1986-01-10 under 510(k) number K854745. 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 CUSTO VIT PULMONARY FUNCTION ANALYSIS SYSTEM?

CUSTO VIT PULMONARY FUNCTION ANALYSIS SYSTEM is a medical device that received FDA 510(k) clearance on 1986-01-10. The listed applicant is Versacor, Inc.. The 510(k) number is K854745.

When did CUSTO VIT PULMONARY FUNCTION ANALYSIS SYSTEM receive FDA 510(k) clearance?

CUSTO VIT PULMONARY FUNCTION ANALYSIS SYSTEM received FDA 510(k) clearance on 1986-01-10, under 510(k) number K854745.

Who is the listed applicant for CUSTO VIT PULMONARY FUNCTION ANALYSIS SYSTEM?

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

What is the FDA product code for CUSTO VIT PULMONARY FUNCTION ANALYSIS SYSTEM?

The FDA product code for CUSTO VIT PULMONARY FUNCTION 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 Versacor, 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.

K854115CUSTO PORT 24-H ECG AMBULATORY RECORDER

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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