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510(k) K081442

HEART SYNC PEDIATRIC, MODEL PED-100 by Heart Sync, LLC — Product Code LDD

K081442 is an FDA 510(k) premarket notification submitted by Heart Sync, LLC for the device "HEART SYNC PEDIATRIC, MODEL PED-100". The FDA issued a decision of Substantially Equivalent on September 24, 2008. The device falls under product code LDD (Dc-Defibrillator, Low-Energy, (Including Paddles)), a Class II device regulated under 21 CFR 870.5300. Heart Sync, LLC has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 2008
Date Received
May 22, 2008
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 Heart Sync, LLC

  • K131550 — HEART SYNC (December 6, 2013)
  • K131494 — HEART SYNC (September 16, 2013)
  • K120536 — HEART SYNC PEDIATRIC PHYSIO AED PAD (August 6, 2012)
  • K080421 — HEART SYNC, MODELS C-100 AND T-100 (February 29, 2008)

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