Medical Device Manufacturer · US , Petaluma , CA

Solo Pace, Inc.

2 submissions · 2 cleared · Since 2025
2
Total
2
Cleared
0
Denied

Solo Pace, Inc. — FDA 510(k) Submissions

Solo Pace, Inc. has submitted 2 FDA 510(k) premarket notifications since 2025, of which 2 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Pulse-generator, Pacemaker, External, Wire, Guide, Catheter . Use the specialty filter in the sidebar to narrow results.

2 devices
1–2 of 2
Filters
All2 Cardiovascular 2