Pure Global

Pacing System Analyzer

Pacing System Analyzer is a medical device type in the Cardiovascular specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes life-sustaining products.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
Multi-Country Intelligence
Pacing System Analyzer
Cardiovascular Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

QAB

View Product Code Classification

Class 2

21 CFR 870.3605

View CFR Regulation

Cardiovascular

Device Characteristics

No

No

Yes

Not Eligible

Definition

The device is intended to supply an accurately calibrated, variable pacing pulse for measuring the patientย’s 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.