Medical Device Manufacturer · US , Petaluma , CA

Solo Pace, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2025
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Solo Pace, Inc. Cardiovascular ✕
2 devices
1-2 of 2
Cleared Jan 09, 2026
Solo Pace Fusion System (SOLOFUSE1)
K252674 · DQX
Cardiovascular · 137d
Cleared Jan 10, 2025
Solo Pace Control
K241781 · DTE
Cardiovascular · 204d
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