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FDA 510(k)

SONACOLOR CD, MODEL 6300 CARDIAC DOPPLER ULTRASOUND

K-Number: K837329 · 1983-06-07

ApplicantCarolina Medical Electronics
Decision Date1983-06-07
Product Code
DecisionSubstantially Equivalent

Device Summary

SONACOLOR CD, MODEL 6300 CARDIAC DOPPLER ULTRASOUND 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 1983-06-07 under 510(k) number K837329. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONACOLOR CD, MODEL 6300 CARDIAC DOPPLER ULTRASOUND?

SONACOLOR CD, MODEL 6300 CARDIAC DOPPLER ULTRASOUND is a medical device that received FDA 510(k) clearance on 1983-06-07. The listed applicant is Carolina Medical Electronics. The 510(k) number is K837329.

When did SONACOLOR CD, MODEL 6300 CARDIAC DOPPLER ULTRASOUND receive FDA 510(k) clearance?

SONACOLOR CD, MODEL 6300 CARDIAC DOPPLER ULTRASOUND received FDA 510(k) clearance on 1983-06-07, under 510(k) number K837329.

Who is the listed applicant for SONACOLOR CD, MODEL 6300 CARDIAC DOPPLER ULTRASOUND?

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

Related Clinical Trials

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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 DS1060K820272CLINIFLOW II, #701, ELECTROMAGN. BLD. SY

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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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