510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801647Substantially Equivalent

Sonacolor 6100

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

K801647 is the FDA 510(k) clearance record for SONACOLOR 6100, a class III device, cleared for Carolina Medical Electronics on under FDA product code DXY (Implantable Pacemaker Pulse-Generator). FDA records list 11 510(k) clearances for Carolina Medical Electronics, from to . As of , FDA records show no recalls naming K801647.

Clearance record

Decision date
Received
(33 days to decision)
Product code
DXY Implantable Pacemaker Pulse-Generator
Regulation
21 CFR 870.3610
Device class
Class III
Review panel
Cardiovascular
Applicant
Carolina Medical Electronics 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DXY

Trailing 12 months

FDA records hold no clearances under product code DXY in the trailing twelve months.

FDA records show no clearances under product code DXY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DXY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260