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FDA 510(k)

L.A.P. SPIROMETER

K-Number: K864836 · 1987-03-06

ApplicantTimeter Instrument Corp.
Decision Date1987-03-06
Product CodeBTY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

L.A.P. SPIROMETER is the device name listed in this FDA 510(k) record. The listed applicant is Timeter Instrument Corp.. It received FDA 510(k) clearance on 1987-03-06 under 510(k) number K864836. 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 L.A.P. SPIROMETER?

L.A.P. SPIROMETER is a medical device that received FDA 510(k) clearance on 1987-03-06. The listed applicant is Timeter Instrument Corp.. The 510(k) number is K864836.

When did L.A.P. SPIROMETER receive FDA 510(k) clearance?

L.A.P. SPIROMETER received FDA 510(k) clearance on 1987-03-06, under 510(k) number K864836.

Who is the listed applicant for L.A.P. SPIROMETER?

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

What is the FDA product code for L.A.P. SPIROMETER?

The FDA product code for L.A.P. SPIROMETER 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 Timeter Instrument 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.

K875075RT-200 COMPUTER INTERFACEK875074VACUMATE INTERMITTENT/CONTINUOUS CONTROLLER,VM2000K871603CRITERION II & IIA OXYGEN CONCENTRATORSK834274CRITERION IK823775BORDON GAGE REGULATOR #BGK822746RT-200 CALIBRATION ANALYZER

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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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