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510(k) K062099

PHASE 3, MODEL DT-1 by Datrend Systems, Inc. — Product Code DRL

K062099 is an FDA 510(k) premarket notification submitted by Datrend Systems, Inc. for the device "PHASE 3, MODEL DT-1". The FDA issued a decision of Substantially Equivalent on January 25, 2007. The device falls under product code DRL (Tester, Defibrillator), a Class II device regulated under 21 CFR 870.5325. Datrend Systems, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 2007
Date Received
July 24, 2006
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 by Datrend Systems, Inc.

  • K980165 — INFUTEST 2000 INFUSION DEVICE ANALYZER (April 20, 1998)

Other clearances for product code DRL

  • K190437 — Delta 3300 (August 28, 2019)
  • K182905 — UniPulse (December 14, 2018)
  • 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)
  • 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