510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011729Substantially Equivalent

Sigma Pace External Pacemaker Analyzer Model #1000

Dni Nevada, Inc., Carson City NV / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011729 is the FDA 510(k) clearance record for SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000, a class II device, cleared for Dni Nevada, Inc. on under FDA product code DTC (Analyzer, Pacemaker Generator Function). FDA records list one 510(k) clearance for Dni Nevada, Inc. As of , FDA records show no recalls naming K011729.

Clearance record

Decision date
Received
(87 days to decision)
Product code
DTC Analyzer, Pacemaker Generator Function
Regulation
21 CFR 870.3630
Device class
Class II
Review panel
Cardiovascular
Applicant
Dni Nevada, Inc. 2000 Arrowhead Dr., Carson City NV
510(k) summary
Summary
Third party review
No

Clearances, product code DTC

Trailing 12 months

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

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