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FDA 510(k)

HMS-4000 PHYSIOLOGICAL MONITOR, MODIFICATION

K-Number: K914620 · 1992-05-01

ApplicantVitalog Monitoring,Inc.
Decision Date1992-05-01
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HMS-4000 PHYSIOLOGICAL MONITOR, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Vitalog Monitoring,Inc.. It received FDA 510(k) clearance on 1992-05-01 under 510(k) number K914620. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HMS-4000 PHYSIOLOGICAL MONITOR, MODIFICATION?

HMS-4000 PHYSIOLOGICAL MONITOR, MODIFICATION is a medical device that received FDA 510(k) clearance on 1992-05-01. The listed applicant is Vitalog Monitoring,Inc.. The 510(k) number is K914620.

When did HMS-4000 PHYSIOLOGICAL MONITOR, MODIFICATION receive FDA 510(k) clearance?

HMS-4000 PHYSIOLOGICAL MONITOR, MODIFICATION received FDA 510(k) clearance on 1992-05-01, under 510(k) number K914620.

Who is the listed applicant for HMS-4000 PHYSIOLOGICAL MONITOR, MODIFICATION?

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

What is the FDA product code for HMS-4000 PHYSIOLOGICAL MONITOR, MODIFICATION?

The FDA product code for HMS-4000 PHYSIOLOGICAL MONITOR, MODIFICATION is DQA.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Vitalog Monitoring,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.

K935510VX4 RECORDING PULSE OXIMETERK914085HMS-5000K910950HMS-4000 MULTICHANNEL PHYSIO MONIT SYST, MODIFIED

Related Devices (Code: DQA)

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.

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbHK252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd.K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)Philips Medizin SystemeK260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Pulse Oximeter (SP61)Avita CorporationK252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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