Siemens Model 146-146A External Pulse G

FDA 510(k) K810566 · Cynergy

Substantially Equivalent

510(k) numberK810566

Submission

Device name
Siemens Model 146-146A External Pulse G
Applicant
Cynergy
Mchenry, IL, US
Received
March 3, 1981
Decision date
April 1, 1981
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
K801596Cynergy Model 184DTE · Traditional 09/16/1980SE
K792536Cynergy Model 182DTE · Traditional 01/31/1980SE
K792223Pacesetter Model 350DTE · Traditional 11/30/1979SE
K781407ERM-101DRT · Traditional 09/27/1978SE

Questions and answers

When was Siemens Model 146-146A External Pulse G cleared by the FDA?

Siemens Model 146-146A External Pulse G (K810566) received a 510(k) decision of Substantially Equivalent on April 1, 1981, 29 days after the submission was received.

What is the product code of K810566?

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