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SigmaPace 1000

FLUKE ELECTRONICS CORPORATION · Model SIGMAP1K-USA120V · UDI-DI 00850540007157

DTC
10
510(k) clearances
3,852
Adverse events (3 deaths)
0
Recalls
6
Facilities

Description

External Pacemaker Analyzer

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.