510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K837329Substantially Equivalent

Sonacolor Cd, Model 6300 Cardiac Doppler Ultrasound

Carolina Medical Electronics, King NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K837329 is the FDA 510(k) clearance record for SONACOLOR CD, MODEL 6300 CARDIAC DOPPLER ULTRASOUND, cleared for Carolina Medical Electronics on . FDA records list 11 510(k) clearances for Carolina Medical Electronics, from to . As of , FDA records show no recalls naming K837329.

Clearance record

Decision date
Received
(91 days to decision)
Review panel
Unknown
Applicant
Carolina Medical Electronics P. O. Box 307, King NC
Third party review
No