FDA 510(k)

Solo Pace Control

K-Number: K241781 · 2025-01-10

Decision Date2025-01-10

Product CodeDTE

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Solo Pace Control is a medical device manufactured by Solo Pace, Inc.. It received FDA 510(k) clearance on 2025-01-10 under approval number K241781. The device is classified under product code DTE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Solo Pace Control?

Solo Pace Control is a medical device that received FDA 510(k) clearance on 2025-01-10. It is manufactured by Solo Pace, Inc.. The 510(k) number is K241781.

When was Solo Pace Control approved by the FDA?

Solo Pace Control received FDA 510(k) clearance on 2025-01-10, under approval number K241781.

What company makes Solo Pace Control?

Solo Pace Control is manufactured by Solo Pace, Inc..

What is the FDA product code for Solo Pace Control?

The FDA product code for Solo Pace Control is DTE.

Other Devices by Solo Pace, Inc.

K252674Solo Pace Fusion System (SOLOFUSE1)

Related Devices (Code: DTE)

K162054Medtronic Temporary External Pacemaker 53401Medtronic, Inc. K162550Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc. K181973Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc. K180873Medtronic Model 53401 External Pulse Generator (EPG)Medtronic, Inc. K190825Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc. K182839Lifetech Cardio Model 8301 Temporary PacemakerShenzhen Lifetech Cardio Medical Electronics Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.