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510(k) K011729

SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000 by Dni Nevada, Inc. — Product Code DTC

K011729 is an FDA 510(k) premarket notification submitted by Dni Nevada, Inc. for the device "SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000". The FDA issued a decision of Substantially Equivalent on August 30, 2001. The device falls under product code DTC (Analyzer, Pacemaker Generator Function), a Class II device regulated under 21 CFR 870.3630.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2001
Date Received
June 4, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Pacemaker Generator Function
Device Class
Class II
Regulation Number
870.3630
Review Panel
CV
Submission Type

Other clearances for product code DTC

  • K170815 — PSA Cable (July 6, 2017)
  • K083674 — PK-141 PATIENT CABLE (April 1, 2009)
  • K002497 — MODEL 4810 ANALYZER OUTPUT ADAPTER (October 10, 2000)
  • K961582 — EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100 (November 8, 1996)
  • K903966 — EXTERNAL PACEMAKER ANALYZER MODEL PMA-1 (June 19, 1991)
  • K910595 — MODEL 5311B A-V PACING SYSTEM ANALYZER (May 7, 1991)
  • K910223 — CPI MODEL 2215/SEAMED MODEL 3400 (March 19, 1991)
  • K901332 — PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE (May 9, 1990)
  • K896632 — MEDTRONIC MODEL 5401B TEST CABLE (December 13, 1989)
  • K884331 — MEDTRONIC MODEL 5311B A-V PACING SYSTEM ANALYZER (January 10, 1989)

FDA data resources