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FDA 510(k)

QFLOW 500 PERFUSION MONITORING SYSTEM

K-Number: K013376 · 2002-05-08

ApplicantHemedex Incorporated
Decision Date2002-05-08
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

QFLOW 500 PERFUSION MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hemedex Incorporated. It received FDA 510(k) clearance on 2002-05-08 under 510(k) number K013376. 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 QFLOW 500 PERFUSION MONITORING SYSTEM?

QFLOW 500 PERFUSION MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2002-05-08. The listed applicant is Hemedex Incorporated. The 510(k) number is K013376.

When did QFLOW 500 PERFUSION MONITORING SYSTEM receive FDA 510(k) clearance?

QFLOW 500 PERFUSION MONITORING SYSTEM received FDA 510(k) clearance on 2002-05-08, under 510(k) number K013376.

Who is the listed applicant for QFLOW 500 PERFUSION MONITORING SYSTEM?

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

What is the FDA product code for QFLOW 500 PERFUSION MONITORING SYSTEM?

The FDA product code for QFLOW 500 PERFUSION MONITORING SYSTEM is DPW.

Related Clinical Trials

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Other records listing Hemedex Incorporated 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.

K032127HEMEDEX FIXATION DEVICEK032337HEMEDEX CRANIAL BOLT MODELS, 3601, 3602

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

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