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510(k) K100654

ZOLL PROPAQ MD by Zoll Medical Corporation, World Wide Headquarters — Product Code LDD

K100654 is an FDA 510(k) premarket notification submitted by Zoll Medical Corporation, World Wide Headquarters for the device "ZOLL PROPAQ MD". The FDA issued a decision of Substantially Equivalent on July 29, 2010. The device falls under product code LDD (Dc-Defibrillator, Low-Energy, (Including Paddles)), a Class II device regulated under 21 CFR 870.5300. Zoll Medical Corporation, World Wide Headquarters has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2010
Date Received
March 8, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dc-Defibrillator, Low-Energy, (Including Paddles)
Device Class
Class II
Regulation Number
870.5300
Review Panel
CV
Submission Type

Other clearances by Zoll Medical Corporation, World Wide Headquarters

  • K133239 — ZOLL E SERIES (January 16, 2015)
  • K133269 — ZOLL X SERIES (May 22, 2014)
  • K120406 — ZOLL FULLY AUTOMATIC AED PLUS (October 26, 2012)
  • K120907 — ZOLL R SERIES (September 25, 2012)
  • K112761 — ZOLL PROPAQ MD (April 25, 2012)
  • K112432 — ZOLL X SERIES (March 21, 2012)
  • K111296 — ZOLL RESCUENETLINK (October 27, 2011)
  • K111594 — ZOLL E SERIES (August 17, 2011)
  • K110361 — ZOLL R SERIES WITH 2010 AHA GUIDELINES SOFTWARE UPDATE (March 8, 2011)
  • K110154 — ZOLL AED PLUS WITH 2010 AHA GUIDLINES SOFTWARE UPDATE (February 17, 2011)

Other clearances for product code LDD

  • K203231 — Switched Internal Paddles (January 11, 2021)
  • K200849 — Tempus LS - Manual (July 24, 2020)
  • K182503 — Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators (June 3, 2019)
  • K150349 — Rapid Hair Removal Pads (July 14, 2015)
  • K140502 — ZOLL E SERIES ALS (November 6, 2014)
  • K103651 — CARDIOMED (October 4, 2011)
  • K103783 — EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDI (June 16, 2011)
  • K103334 — CARDIO MED (January 18, 2011)
  • K103159 — CARDIO MED MODEL A102, H104, O101, P103, AND Z100 (January 11, 2011)
  • K102468 — ZOLL PROPAQ MD (September 30, 2010)

FDA data resources