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FDA 510(k)

SONACOLOR 6000

K-Number: K792540 · 1980-01-17

ApplicantCarolina Medical Electronics
Decision Date1980-01-17
Product CodeDXK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SONACOLOR 6000 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 1980-01-17 under 510(k) number K792540. The device is classified under product code DXK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONACOLOR 6000?

SONACOLOR 6000 is a medical device that received FDA 510(k) clearance on 1980-01-17. The listed applicant is Carolina Medical Electronics. The 510(k) number is K792540.

When did SONACOLOR 6000 receive FDA 510(k) clearance?

SONACOLOR 6000 received FDA 510(k) clearance on 1980-01-17, under 510(k) number K792540.

Who is the listed applicant for SONACOLOR 6000?

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 SONACOLOR 6000?

The FDA product code for SONACOLOR 6000 is DXK.

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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 DOPPLERK874685TRANS-SCAN 3-D TRANSCRANIAL DOPPLERK864624PROBE, UPTAKE, NUCLEARK843891DOPSCAN PLUS DS1060K837329SONACOLOR CD, MODEL 6300 CARDIAC DOPPLER ULTRASOUND

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Related Devices (Code: DXK)

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.

K181042Ultra ICE Plus – PI 9 MHz Peripheral Imaging CatheterBoston Scientific CorporationK160173Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)Boston Scientific CorporationK031148IN-VISION IMAGING SYSTEMJomed, Inc.K9348879750 ATHENA ETHERNET OPTIONS & W Medico Teknik A/SK913209ACCESSORY TO GENESIS III (GCFM)Biosound, Inc.K911384CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600Endosonics Corp.

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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