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FDA 510(k)

APEXLINE OF PULMONARY FUNCT. INSTRUM.

K-Number: K803053 · 1980-12-22

ApplicantWarren E. Collins, Inc.
Decision Date1980-12-22
Product CodeBTY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

APEXLINE OF PULMONARY FUNCT. INSTRUM. is the device name listed in this FDA 510(k) record. The listed applicant is Warren E. Collins, Inc.. It received FDA 510(k) clearance on 1980-12-22 under 510(k) number K803053. 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 APEXLINE OF PULMONARY FUNCT. INSTRUM.?

APEXLINE OF PULMONARY FUNCT. INSTRUM. is a medical device that received FDA 510(k) clearance on 1980-12-22. The listed applicant is Warren E. Collins, Inc.. The 510(k) number is K803053.

When did APEXLINE OF PULMONARY FUNCT. INSTRUM. receive FDA 510(k) clearance?

APEXLINE OF PULMONARY FUNCT. INSTRUM. received FDA 510(k) clearance on 1980-12-22, under 510(k) number K803053.

Who is the listed applicant for APEXLINE OF PULMONARY FUNCT. INSTRUM.?

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

What is the FDA product code for APEXLINE OF PULMONARY FUNCT. INSTRUM.?

The FDA product code for APEXLINE OF PULMONARY FUNCT. INSTRUM. is BTY.

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Other records listing Warren E. Collins, 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.

K925459GS-MODULAR (GOLD STANDARD - MODULAR)K912946COLLINS DIGITAL PULMONARY MANOMETERK871151THE SPIRA ELEKTRO 2K861227COLLINS PNEUMOTACH PFT SYSTEMK852102COLLIN BODY PLETHYSMOGRAPH PLUS SYSTEMK831780METABOLIC EXERCISE TESTING SYSTEM

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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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