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FDA 510(k)

TC2-64B TRANSCRANIAL DOPPLER

K-Number: K874684 · 1988-04-25

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

Device Summary

TC2-64B 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 K874684. 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 TC2-64B TRANSCRANIAL DOPPLER?

TC2-64B 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 K874684.

When did TC2-64B TRANSCRANIAL DOPPLER receive FDA 510(k) clearance?

TC2-64B TRANSCRANIAL DOPPLER received FDA 510(k) clearance on 1988-04-25, under 510(k) number K874684.

Who is the listed applicant for TC2-64B 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 TC2-64B TRANSCRANIAL DOPPLER?

The FDA product code for TC2-64B 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 PLETHYSMOGRAPHK874685TRANS-SCAN 3-D TRANSCRANIAL DOPPLERK864624PROBE, UPTAKE, NUCLEARK843891DOPSCAN PLUS DS1060K837329SONACOLOR CD, MODEL 6300 CARDIAC DOPPLER ULTRASOUNDK820272CLINIFLOW II, #701, ELECTROMAGN. BLD. SY

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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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