510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800376Substantially Equivalent

Epr-200 Programmer Model 010

Biotronik Sales, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800376 is the FDA 510(k) clearance record for EPR-200 PROGRAMMER MODEL 010, a class III device, cleared for Biotronik Sales, Inc. on under FDA product code KRG (Programmer, Pacemaker). FDA records list 41 510(k) clearances for Biotronik Sales, Inc., from to . As of , FDA records show no recalls naming K800376.

Clearance record

Decision date
Received
(60 days to decision)
Product code
KRG Programmer, Pacemaker
Regulation
21 CFR 870.3700
Device class
Class III
Review panel
Cardiovascular
Applicant
Biotronik Sales, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KRG

Trailing 12 months

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

FDA records show no clearances under product code KRG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KRG, 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