FDA.reportPublic FDA data

510(k) K241781

Device
Solo Pace Control
Applicant
Solo Pace, Inc.
510(k) number
K241781
Product code
DTE
Decision
Substantially Equivalent (SESE)
Decision date
2025-01-10
Date received
2024-06-20
Regulation
870.3600
Classification name
Pulse-Generator, Pacemaker, External
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
David Daniels
Address
1030 B St. Petaluma CA US 94952 94952

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DTE#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K232721Lifetech Cardio Temporary PacemakerShenzhen Lifetech Cardio Medical Electronics Co., Ltd.2024-01-07
K201011Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc.2020-05-13
K190825Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc.2019-04-30
K182839Lifetech Cardio Model 8301 Temporary PacemakerShenzhen Lifetech Cardio Medical Electronics Co., Ltd.2019-02-28
K181973Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc.2018-08-21
K180873Medtronic Model 53401 External Pulse Generator (EPG)Medtronic, Inc.2018-04-19
K162054Medtronic Temporary External Pacemaker 53401Medtronic, Inc.2016-10-18
K162550Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc.2016-10-12
K150246Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc.2015-02-18
K132924MEDTRONIC EXTERNAL PULSE GENERATOR (EPG)Medtronic, Inc.2013-10-31
K123916PSA SERIESOsypka Medical, Inc.2013-04-09
K042708ERA 3000 PACING SYSTEM ANALYZERBiotronik, Inc.2004-10-20
K033130PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOROsypka Medical, Inc.2003-10-31
K023080GALIX PACESTARGalix Biomedical Instrumentation, Inc.2003-06-11
K022939OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES,CARDIOTRONIC PACE 101 AND ACCESSORIESOsypka Medical, Inc.2002-10-03