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510(k) K963190

QA-40M DEFIBRILLATOR TESTER by Metron U.S., Inc. — Product Code DRL

K963190 is an FDA 510(k) premarket notification submitted by Metron U.S., Inc. for the device "QA-40M DEFIBRILLATOR TESTER". The FDA issued a decision of Substantially Equivalent on July 1, 1997. The device falls under product code DRL (Tester, Defibrillator), a Class II device regulated under 21 CFR 870.5325. Metron U.S., Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1997
Date Received
August 15, 1996
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 Metron U.S., Inc.

  • K982020 — METRON QA-IDS I.V. PUMP TESTER (September 30, 1998)
  • K973991 — METRON QA-510 SPO2 ANALYZER (January 16, 1998)
  • K963198 — PS-41 6M PATIENT SIMULATOR (March 5, 1997)

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)
  • K062099 — PHASE 3, MODEL DT-1 (January 25, 2007)
  • K030547 — MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE (July 11, 2003)
  • 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