# Pacing System Analyzer
> **Product code: QAB** · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.3605
## Classification
- **FDA Product Code:** QAB
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 870.3605
- **Review panel:** CV
- **Medical specialty:** Cardiovascular
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** Y
- **Implant:** N
- **Third-party review:** N
## Definition

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

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 0
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QAB)
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