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FDA 510(k)

HIGH VELOCITY CW DOPPLER SYSTEM

K-Number: K862841 · 1986-11-10

ApplicantBiosound, Inc.
Decision Date1986-11-10
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HIGH VELOCITY CW DOPPLER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biosound, Inc.. It received FDA 510(k) clearance on 1986-11-10 under 510(k) number K862841. 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 HIGH VELOCITY CW DOPPLER SYSTEM?

HIGH VELOCITY CW DOPPLER SYSTEM is a medical device that received FDA 510(k) clearance on 1986-11-10. The listed applicant is Biosound, Inc.. The 510(k) number is K862841.

When did HIGH VELOCITY CW DOPPLER SYSTEM receive FDA 510(k) clearance?

HIGH VELOCITY CW DOPPLER SYSTEM received FDA 510(k) clearance on 1986-11-10, under 510(k) number K862841.

Who is the listed applicant for HIGH VELOCITY CW DOPPLER SYSTEM?

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

What is the FDA product code for HIGH VELOCITY CW DOPPLER SYSTEM?

The FDA product code for HIGH VELOCITY CW DOPPLER SYSTEM is DPW.

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Other records listing Biosound, 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.

K971700BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCERK963936ACCESSPOINT, MED E-MAIL, DICOM READERK963262ARTOSCAN MK963662GALILEO EVOKED POTENTIALREK953716INTRACAVITY TRANSDUCERSK953530DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A

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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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