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FDA 510(k)

TRANS-SCAN 3-D TRANSCRANIAL DOPPLER

K-Number: K874685 · 1988-04-25

ApplicantCarolina Medical Electronics
Decision Date1988-04-25
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TRANS-SCAN 3-D TRANSCRANIAL DOPPLER 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 1988-04-25 under 510(k) number K874685. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANS-SCAN 3-D TRANSCRANIAL DOPPLER?

TRANS-SCAN 3-D TRANSCRANIAL DOPPLER is a medical device that received FDA 510(k) clearance on 1988-04-25. The listed applicant is Carolina Medical Electronics. The 510(k) number is K874685.

When did TRANS-SCAN 3-D TRANSCRANIAL DOPPLER receive FDA 510(k) clearance?

TRANS-SCAN 3-D TRANSCRANIAL DOPPLER received FDA 510(k) clearance on 1988-04-25, under 510(k) number K874685.

Who is the listed applicant for TRANS-SCAN 3-D TRANSCRANIAL DOPPLER?

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 TRANS-SCAN 3-D TRANSCRANIAL DOPPLER?

The FDA product code for TRANS-SCAN 3-D TRANSCRANIAL DOPPLER is IYO.

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Other records listing Carolina Medical Electronics 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.

K914200VASCUMAP MEDICAL AIR PLETHYSMOGRAPHK874684TC2-64B TRANSCRANIAL DOPPLERK864624PROBE, UPTAKE, NUCLEARK843891DOPSCAN PLUS DS1060K837329SONACOLOR CD, MODEL 6300 CARDIAC DOPPLER ULTRASOUNDK820272CLINIFLOW II, #701, ELECTROMAGN. BLD. SY

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Related Devices (Code: IYO)

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, 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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