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510(k) K853194

ERA-20 by Biotronik Sales, Inc. — Product Code DTE

K853194 is an FDA 510(k) premarket notification submitted by Biotronik Sales, Inc. for the device "ERA-20". The FDA issued a decision of Substantially Equivalent on March 11, 1987. The device falls under product code DTE (Pulse-Generator, Pacemaker, External), a Class II device regulated under 21 CFR 870.3600. Biotronik Sales, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1987
Date Received
July 30, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pulse-Generator, Pacemaker, External
Device Class
Class II
Regulation Number
870.3600
Review Panel
CV
Submission Type

Other clearances by Biotronik Sales, Inc.

  • K875199 — NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTOR (February 18, 1988)
  • K860036 — EDP-20 PACEMAKER (January 12, 1987)
  • K863879 — NEOS-M VS-1 PULSE GENERATOR (December 10, 1986)
  • K863878 — TRIOS-M VS-1 PULSE GENERATOR (December 10, 1986)
  • K863480 — BIOTRONIK PERMANENT PACEMAKER ELECTRODE (September 23, 1986)
  • K860921 — NEOS VS-1, PULSE GENERATOR (August 8, 1986)
  • K860922 — MIKROS, MIKROS VS-1, PULSE GENERATOR (August 4, 1986)
  • K853567 — DJP UNIPOLAR (May 7, 1986)
  • K853566 — DJ UNIPOLAR (May 7, 1986)
  • K853568 — DNR UNIPOLAR (January 15, 1986)

Other clearances for product code DTE

  • K241781 — Solo Pace Control (January 10, 2025)
  • K232721 — Lifetech Cardio Temporary Pacemaker (January 7, 2024)
  • K201011 — Medtronic Model 5392 External Pulse Generator (EPG) (May 13, 2020)
  • K190825 — Medtronic Model 5392 External Pulse Generator (EPG) (April 30, 2019)
  • K182839 — Lifetech Cardio Model 8301 Temporary Pacemaker (February 28, 2019)
  • K181973 — Medtronic Model 5392 External Pulse Generator (EPG) (August 21, 2018)
  • K180873 — Medtronic Model 53401 External Pulse Generator (EPG) (April 19, 2018)
  • K162054 — Medtronic Temporary External Pacemaker 53401 (October 18, 2016)
  • K162550 — Medtronic Model 5392 External Pulse Generator (EPG) (October 12, 2016)
  • K150246 — Medtronic Model 5392 External Pulse Generator (EPG) (February 18, 2015)

FDA data resources