Cleared Traditional

K837329 - SONACOLOR CD, MODEL 6300 CARDIAC DOPPLER ULTRASOUND

K837329 · Carolina Medical Electronics · Radiology device
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Jun 1983
Decision
91d
Days
-
Risk

K837329 is an FDA 510(k) clearance for the SONACOLOR CD, MODEL 6300 CARDIAC DOPPLER ULTRASOUND.

Submitted by Carolina Medical Electronics (King, US). The FDA issued a Cleared decision on June 7, 1983 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K837329

510(k) Number K837329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1983
Decision Date June 07, 1983
Days to Decision 91 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 107d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -