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510(k) K182905

UniPulse by Seaward Group — Product Code DRL

K182905 is an FDA 510(k) premarket notification submitted by Seaward Group for the device "UniPulse". The FDA issued a decision of Substantially Equivalent on December 14, 2018. The device falls under product code DRL (Tester, Defibrillator), a Class II device regulated under 21 CFR 870.5325.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2018
Date Received
October 16, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tester, Defibrillator
Device Class
Class II
Regulation Number
870.5325
Review Panel
CV
Submission Type

Other clearances for product code DRL

  • K190437 — Delta 3300 (August 28, 2019)
  • K153210 — Defibrillator Analyzer Variable Load (December 21, 2015)
  • K110192 — DEFIBRILLATOR ANALYZER - DA-2006P (February 8, 2011)
  • K083347 — IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS (December 24, 2008)
  • K072114 — IMPULSE 6000D/7000DP (January 28, 2008)
  • K062099 — PHASE 3, MODEL DT-1 (January 25, 2007)
  • K030547 — MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE (July 11, 2003)
  • K963190 — QA-40M DEFIBRILLATOR TESTER (July 1, 1997)
  • K961595 — DEFIBRILLATOR ANALYZER, DELTA 1000 (October 29, 1996)
  • K954391 — MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER (November 17, 1995)

FDA data resources