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FDA 510(k)

DOPSCAN MODEL 1050

K-Number: K810561 · 1981-04-10

ApplicantCarolina Medical Electronics
Decision Date1981-04-10
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DOPSCAN MODEL 1050 is the device name listed in this FDA 510(k) record. The listed applicant is Carolina Medical Electronics. It received FDA 510(k) clearance on 1981-04-10 under 510(k) number K810561. 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 DOPSCAN MODEL 1050?

DOPSCAN MODEL 1050 is a medical device that received FDA 510(k) clearance on 1981-04-10. The listed applicant is Carolina Medical Electronics. The 510(k) number is K810561.

When did DOPSCAN MODEL 1050 receive FDA 510(k) clearance?

DOPSCAN MODEL 1050 received FDA 510(k) clearance on 1981-04-10, under 510(k) number K810561.

Who is the listed applicant for DOPSCAN MODEL 1050?

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

What is the FDA product code for DOPSCAN MODEL 1050?

The FDA product code for DOPSCAN MODEL 1050 is DPW.

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Other records listing Carolina Medical Electronics as applicant

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K914200VASCUMAP MEDICAL AIR PLETHYSMOGRAPHK874684TC2-64B TRANSCRANIAL DOPPLERK874685TRANS-SCAN 3-D TRANSCRANIAL DOPPLERK864624PROBE, UPTAKE, NUCLEARK843891DOPSCAN PLUS DS1060K837329SONACOLOR CD, MODEL 6300 CARDIAC DOPPLER ULTRASOUND

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Related Devices (Code: DPW)

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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

View on FDA Database →

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

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