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FDA 510(k)

ST-90 SPIRO ANALIZER

K-Number: K861487 · 1986-06-23

ApplicantFuture Impex Corp.
Decision Date1986-06-23
Product CodeBTY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ST-90 SPIRO ANALIZER is the device name listed in this FDA 510(k) record. The listed applicant is Future Impex Corp.. It received FDA 510(k) clearance on 1986-06-23 under 510(k) number K861487. 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 ST-90 SPIRO ANALIZER?

ST-90 SPIRO ANALIZER is a medical device that received FDA 510(k) clearance on 1986-06-23. The listed applicant is Future Impex Corp.. The 510(k) number is K861487.

When did ST-90 SPIRO ANALIZER receive FDA 510(k) clearance?

ST-90 SPIRO ANALIZER received FDA 510(k) clearance on 1986-06-23, under 510(k) number K861487.

Who is the listed applicant for ST-90 SPIRO ANALIZER?

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

What is the FDA product code for ST-90 SPIRO ANALIZER?

The FDA product code for ST-90 SPIRO ANALIZER is BTY.

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Other records listing Future Impex 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.

K854687ERMA HB-METER MODEL 303NK854686TE-25 COAGURO METERK854685DIGITAL-9 KEY LEUCOCYTE COUNTERK854677ERMA PC-604 BLOOD CELL COUNTERK854678ERMA PC-602 PC-603 BLOOD CELL COUNTERK854679PHOTIC-100 SPECTROPHOTOMETER

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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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