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FDA 510(k)

PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040)

K-Number: K990960 · 1999-09-23

ApplicantPerimed, Inc.
Decision Date1999-09-23
Product CodeLKD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040) is the device name listed in this FDA 510(k) record. The listed applicant is Perimed, Inc.. It received FDA 510(k) clearance on 1999-09-23 under 510(k) number K990960. The device is classified under product code LKD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040)?

PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040) is a medical device that received FDA 510(k) clearance on 1999-09-23. The listed applicant is Perimed, Inc.. The 510(k) number is K990960.

When did PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040) receive FDA 510(k) clearance?

PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040) received FDA 510(k) clearance on 1999-09-23, under 510(k) number K990960.

Who is the listed applicant for PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040)?

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

What is the FDA product code for PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040)?

The FDA product code for PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040) is LKD.

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 Perimed, 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.

K974285PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT MODEL PF 5001, INCLUDING PF 5010 LDPM UNITK935495PF404/409/410/411/416/418 W/PF319:0/319:1/319:2K932068PERITEMP PF 4005 HEATERK922368PERIFLUX PF4001 LASER DOPPLER FLOWMETERK890828PERIFLUX PF3

Related Devices (Code: LKD)

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.

K232516Sentec Digital Monitoring System (SDMS) tCOM+Sentec AGK131253PERIFLUX 6000Perimed ABK110474PHILIPS INTELLIVUE TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac ANK101690SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLESentec AGK093154TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEMRadiometer Medical ApsK043357TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009Linde Medical Sensors AG

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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