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FDA 510(k)

SPIROMETRICS 2453 & SMI III

K-Number: K850045 · 1985-02-14

ApplicantSpirometrics, Inc.
Decision Date1985-02-14
Product CodeBTY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPIROMETRICS 2453 & SMI III is the device name listed in this FDA 510(k) record. The listed applicant is Spirometrics, Inc.. It received FDA 510(k) clearance on 1985-02-14 under 510(k) number K850045. 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 SPIROMETRICS 2453 & SMI III?

SPIROMETRICS 2453 & SMI III is a medical device that received FDA 510(k) clearance on 1985-02-14. The listed applicant is Spirometrics, Inc.. The 510(k) number is K850045.

When did SPIROMETRICS 2453 & SMI III receive FDA 510(k) clearance?

SPIROMETRICS 2453 & SMI III received FDA 510(k) clearance on 1985-02-14, under 510(k) number K850045.

Who is the listed applicant for SPIROMETRICS 2453 & SMI III?

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

What is the FDA product code for SPIROMETRICS 2453 & SMI III?

The FDA product code for SPIROMETRICS 2453 & SMI III is BTY.

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Other records listing Spirometrics, 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.

K915059PEAK FLOW MONITORK911358CMD/DLCO DIAGNOSTIC SPIROMETERK900322CO/CMD-1K901057SPIROMETRICS MODEL 2600 MIRO SPIROMETERK900673SERIAL FLOWK884464SPIROMETRICS MODEL 2200 SM200 FLOW SENSOR

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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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