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FDA 510(k)

VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS

K-Number: K942211 · 1994-11-22

ApplicantSensor Medics Corp.
Decision Date1994-11-22
Product CodeBTY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Sensor Medics Corp.. It received FDA 510(k) clearance on 1994-11-22 under 510(k) number K942211. 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 VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS?

VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS is a medical device that received FDA 510(k) clearance on 1994-11-22. The listed applicant is Sensor Medics Corp.. The 510(k) number is K942211.

When did VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS receive FDA 510(k) clearance?

VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS received FDA 510(k) clearance on 1994-11-22, under 510(k) number K942211.

Who is the listed applicant for VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS?

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

What is the FDA product code for VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS?

The FDA product code for VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS is BTY.

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Other records listing Sensor Medics Corp. as applicant

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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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