Pacesetter Model 350

FDA 510(k) K792223 · Cynergy

Substantially Equivalent

510(k) numberK792223

Submission

Device name
Pacesetter Model 350
Applicant
Cynergy
Mchenry, IL, US
Received
November 5, 1979
Decision date
November 30, 1979
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DTE – Pulse-Generator, Pacemaker, External
Device class
Class II (moderate risk)
Regulation
21 CFR 870.3600
Specialty
Cardiovascular

Other 510(k)s with product code DTE

510(k)DeviceApplicantDecision
K241781Solo Pace ControlDTE · Traditional Solo Pace, Inc.01/10/2025SE
K232721Lifetech Cardio Temporary PacemakerDTE · Special Shenzhen Lifetech Cardio Medical Electronics…01/07/2024SE
K201011Medtronic Model 5392 External Pulse Generator (EPG)DTE · Special Medtronic, Inc.05/13/2020SE
K190825Medtronic Model 5392 External Pulse Generator (EPG)DTE · Special Medtronic, Inc.04/30/2019SE
K182839Lifetech Cardio Model 8301 Temporary PacemakerDTE · Traditional Shenzhen Lifetech Cardio Medical Electronics…02/28/2019SE
K181973Medtronic Model 5392 External Pulse Generator (EPG)DTE · Special Medtronic, Inc.08/21/2018SE
K180873Medtronic Model 53401 External Pulse Generator (EPG)DTE · Special Medtronic, Inc.04/19/2018SE
K162054Medtronic Temporary External Pacemaker 53401DTE · Traditional Medtronic, Inc.10/18/2016SE
K162550Medtronic Model 5392 External Pulse Generator (EPG)DTE · Special Medtronic, Inc.10/12/2016SE
K150246Medtronic Model 5392 External Pulse Generator (EPG)DTE · Special Medtronic, Inc.02/18/2015SE

More from Medtronic, Inc.

510(k)DeviceDecision
K810566Siemens Model 146-146A External Pulse GDTE · Traditional 04/01/1981SE
K801596Cynergy Model 184DTE · Traditional 09/16/1980SE
K792536Cynergy Model 182DTE · Traditional 01/31/1980SE
K781407ERM-101DRT · Traditional 09/27/1978SE

Questions and answers

When was Pacesetter Model 350 cleared by the FDA?

Pacesetter Model 350 (K792223) received a 510(k) decision of Substantially Equivalent on November 30, 1979, 25 days after the submission was received.

What is the product code of K792223?

The FDA product code is DTE – Pulse-Generator, Pacemaker, External, a Class II (moderate risk) device regulated under 21 CFR 870.3600.