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510(k) K933069

MODEL EP-2 CLINICAL STIMULATOR by Ep Medical, Inc. — Product Code DTA

K933069 is an FDA 510(k) premarket notification submitted by Ep Medical, Inc. for the device "MODEL EP-2 CLINICAL STIMULATOR". The FDA issued a decision of Substantially Equivalent on October 21, 1993. The device falls under product code DTA (Tester, Pacemaker Electrode Function), a Class II device regulated under 21 CFR 870.3720. Ep Medical, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 1993
Date Received
June 22, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tester, Pacemaker Electrode Function
Device Class
Class II
Regulation Number
870.3720
Review Panel
CV
Submission Type

Other clearances by Ep Medical, Inc.

  • K935590 — EP MEDICAL, INC. EP-3 CLINICAL STIMULATOR (May 5, 1994)
  • K901320 — ABSORBENT, DISPOSABLE URINARY DRAINAGE BAG (January 25, 1991)

Other clearances for product code DTA

  • K163008 — CareLink SmartSync Device Manager - Pacing System Analyzer (February 28, 2017)
  • K101982 — MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180 (December 21, 2010)
  • K073230 — MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS (December 20, 2007)
  • K050884 — ADAPTER CABLE (May 19, 2005)
  • K033613 — MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER (December 8, 2003)
  • K022360 — ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA (January 27, 2003)
  • K812104 — SIEMENS-ELEMA PSA 376 (December 2, 1981)
  • K791380 — VA 1000 (September 19, 1979)
  • K790503 — CARDIOTEST 2200 (May 17, 1979)

FDA data resources