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510(k) K102542

RESUSCI FLOW; RESUSCI FLOW 104 by Atom Medical Corporation — Product Code BTL

K102542 is an FDA 510(k) premarket notification submitted by Atom Medical Corporation for the device "RESUSCI FLOW; RESUSCI FLOW 104". The FDA issued a decision of Substantially Equivalent on April 6, 2011. The device falls under product code BTL (Ventilator, Emergency, Powered (Resuscitator)), a Class II device regulated under 21 CFR 868.5925. Atom Medical Corporation has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 2011
Date Received
September 3, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Emergency, Powered (Resuscitator)
Device Class
Class II
Regulation Number
868.5925
Review Panel
AN
Submission Type

Other clearances by Atom Medical Corporation

  • K123937 — ATOM TRANSCAPSULE V-707 (May 23, 2013)
  • K120937 — SUNFLOWER WARNER (July 6, 2012)
  • K111547 — BILI-THERAPY PAD TYPE (April 12, 2012)
  • K103317 — RESUSCITATION UNIT 105 (April 20, 2011)
  • K103828 — BILI-THERAPY SPOT TYPE (March 29, 2011)
  • K102227 — INFA WARMER I (January 21, 2011)
  • K102226 — DUAL INCU I (January 4, 2011)
  • K102279 — INCU I (December 29, 2010)
  • K102710 — NEO-SERVO I (December 22, 2010)

Other clearances for product code BTL

  • K242769 — VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) (April 4, 2025)
  • K221634 — Oxymag - Transport and Emergency Ventilator (May 24, 2023)
  • K202219 — VORTRAN GO2VENT with PEEP Valve (February 11, 2021)
  • K193191 — MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag (November 20, 2020)
  • K182956 — Puffin Lite Infant Resuscitation System (January 18, 2019)
  • K173373 — SafeT T-Piece Resuscitator (November 16, 2018)
  • K161420 — MOVES SLC (June 6, 2017)
  • K162968 — VORTRAN GO2VENT (April 10, 2017)
  • K141595 — O-TWO E700,O-TWO E600,O-TWO E500 (March 16, 2015)
  • K142096 — T-PIECE RESUSCITATOR (October 17, 2014)

FDA data resources