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FDA 510(k)

PERIFLUX PF4001 LASER DOPPLER FLOWMETER

K-Number: K922368 · 1993-02-03

ApplicantPerimed, Inc.
Decision Date1993-02-03
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PERIFLUX PF4001 LASER DOPPLER FLOWMETER is the device name listed in this FDA 510(k) record. The listed applicant is Perimed, Inc.. It received FDA 510(k) clearance on 1993-02-03 under 510(k) number K922368. The device is classified under product code DPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERIFLUX PF4001 LASER DOPPLER FLOWMETER?

PERIFLUX PF4001 LASER DOPPLER FLOWMETER is a medical device that received FDA 510(k) clearance on 1993-02-03. The listed applicant is Perimed, Inc.. The 510(k) number is K922368.

When did PERIFLUX PF4001 LASER DOPPLER FLOWMETER receive FDA 510(k) clearance?

PERIFLUX PF4001 LASER DOPPLER FLOWMETER received FDA 510(k) clearance on 1993-02-03, under 510(k) number K922368.

Who is the listed applicant for PERIFLUX PF4001 LASER DOPPLER FLOWMETER?

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 PERIFLUX PF4001 LASER DOPPLER FLOWMETER?

The FDA product code for PERIFLUX PF4001 LASER DOPPLER FLOWMETER is DPW.

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.

K990960PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040)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 HEATERK890828PERIFLUX PF3

Related Devices (Code: DPW)

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.

K260700BlueDop Vascular ExpertBlueDop Medical, Ltd.K252810FloPatch FP120Flosonics MedicalK251904VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01)Remington Medical, Inc.K251114FloPatch FP120Flosonics MedicalK243852Elfor-LElfi-Tech , Ltd.K241583VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01)Remington Medical, Inc.

Official Source

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