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510(k) K791380

VA 1000 by Vitatron Medical BV — Product Code DTA

K791380 is an FDA 510(k) premarket notification submitted by Vitatron Medical BV for the device "VA 1000". The FDA issued a decision of Substantially Equivalent on September 19, 1979. The device falls under product code DTA (Tester, Pacemaker Electrode Function), a Class II device regulated under 21 CFR 870.3720. Vitatron Medical BV has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 1979
Date Received
July 24, 1979
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 Vitatron Medical BV

  • K854790 — CERYX PACEMAKER MODELS 114, 314 & 614 (August 28, 1986)
  • K844484 — HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEA (July 24, 1985)
  • K844485 — CERYX6, 611, CERYX 3 311 & CERYX 1 111 (April 19, 1985)
  • K844483 — TP 1 (April 19, 1985)
  • K840668 — ELECTRODE PACEMAKER, PERM & TEMP (September 24, 1984)
  • K831859 — PACEMAKER PROGRAMMER #2032 (October 27, 1983)
  • K831860 — GENERATOR, PULSE, PACEMAKER #532 (October 27, 1983)
  • K810928 — ENDOCARDIAL ELECTRODE (July 2, 1981)
  • K791920 — CARDIAC PACEMAKER P4000 SER. & P1000 (November 29, 1979)
  • K791921 — CARDIAC PACEMAKER C4000, C1000 SER. (October 26, 1979)

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)
  • K933069 — MODEL EP-2 CLINICAL STIMULATOR (October 21, 1993)
  • K812104 — SIEMENS-ELEMA PSA 376 (December 2, 1981)
  • K790503 — CARDIOTEST 2200 (May 17, 1979)

FDA data resources