QABClass IILife-sustaining
Pacing System Analyzer
Cardiovascular · 21 CFR 870.3605
The device is intended to supply an accurately calibrated, variable pacing pulse for measuring the patients pacing threshold and intracardiac R-wave potential. A pacing system analyzer (PSA) may be a single, dual, or triple chamber system and can simultaneously deliver pacing therapy while testing one or more implanted pacing leads.
MDR events0All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances0All time
Recent MDR events
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Event type breakdown
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Recalls
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No recalls on file for this product code.
Registered firms
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510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.