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FDA 510(k)

PFT SCREENER (SYSTEM 1100)

K-Number: K812792 · 1981-11-27

ApplicantMedical Graphics Corp.
Decision Date1981-11-27
Product CodeBTY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PFT SCREENER (SYSTEM 1100) is the device name listed in this FDA 510(k) record. The listed applicant is Medical Graphics Corp.. It received FDA 510(k) clearance on 1981-11-27 under 510(k) number K812792. 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 PFT SCREENER (SYSTEM 1100)?

PFT SCREENER (SYSTEM 1100) is a medical device that received FDA 510(k) clearance on 1981-11-27. The listed applicant is Medical Graphics Corp.. The 510(k) number is K812792.

When did PFT SCREENER (SYSTEM 1100) receive FDA 510(k) clearance?

PFT SCREENER (SYSTEM 1100) received FDA 510(k) clearance on 1981-11-27, under 510(k) number K812792.

Who is the listed applicant for PFT SCREENER (SYSTEM 1100)?

The FDA 510(k) record lists Medical Graphics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PFT SCREENER (SYSTEM 1100)?

The FDA product code for PFT SCREENER (SYSTEM 1100) is BTY.

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Other records listing Medical Graphics Corp. 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.

K152585Resmon PRO FULLK070858EXPRESS SERIESK061731MEDGRAPHICS ULTIMA SYSTEMK955432CPX, CCM, CATH WITH 15% CO2K9432591085 ULTIMATE E PLETHYSMOGRAPHK923209MEDGRAPHICS EXERCISE CONSULT

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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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