ERA-20

FDA 510(k) K853194 · Biotronik Sales, Inc.

Substantially Equivalent

510(k) numberK853194

Submission

Device name
ERA-20
Applicant
Biotronik Sales, Inc.
Lake Oswego, OR, US
Received
July 30, 1985
Decision date
March 11, 1987
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
K875199NP Bipolar Endocardial Lead W/VS-1 ConnectorDTB · Traditional 02/18/1988SE
K860036EDP-20 PacemakerDXY · Traditional 01/12/1987SE
K863879Neos-M VS-1 Pulse GeneratorDXY · Traditional 12/10/1986SE
K863878Trios-M VS-1 Pulse GeneratorDXY · Traditional 12/10/1986SE
K863480Biotronik Permanent Pacemaker ElectrodeDTB · Traditional 09/23/1986SE
K860921Neos VS-1, Pulse GeneratorDXY · Traditional 08/08/1986SE
K860922Mikros, Mikros VS-1, Pulse GeneratorDXY · Traditional 08/04/1986SE
K853567DJP UnipolarDTB · Traditional 05/07/1986SE
K853566DJ UnipolarDTB · Traditional 05/07/1986SE
K853568DNR UnipolarDTB · Traditional 01/15/1986SE

Questions and answers

When was ERA-20 cleared by the FDA?

ERA-20 (K853194) received a 510(k) decision of Substantially Equivalent on March 11, 1987, 589 days after the submission was received.

What is the product code of K853194?

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