Home / 510(k) Clearances / K880450

510(k) K880450

RESUSCI PATIENT FACE SHIELD by Laerdal Medical Corp. — Product Code BTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1988
Date Received
February 2, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Emergency, Manual (Resuscitator)
Device Class
Class II
Regulation Number
868.5915
Review Panel
AN
Submission Type

Other clearances by Laerdal Medical Corp.

  • K251631 — The BAG manual resuscitator and accessories (November 24, 2025)
  • K232111 — NeoBeat, NeoBeat Mini (June 25, 2024)
  • K183348 — Reusable Silicone Cover CPRmeter 2 (December 17, 2018)
  • K173886 — CPRmeter 2 CPR Feedback Device (March 23, 2018)
  • K151702 — Reusable Full Silicone Cover (August 13, 2015)
  • K132172 — NEONATALIE RESUSCITATOR (January 15, 2015)
  • K122050 — CPRMETER CPR FEEDBACK DEVICE (October 22, 2012)
  • K023805 — LAERDAL PAEDIATRIC POCKET MASK, MODEL 820050 (February 11, 2003)
  • K001742 — RESUSCI INFLATE-A-SHIELD CPR BARRIER (October 6, 2000)
  • K993668 — LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20 (December 20, 1999)

Other clearances for product code BTM

  • K251631 — The BAG manual resuscitator and accessories (November 24, 2025)
  • K243861 — butterflyBVM (April 25, 2025)
  • K221841 — EOlife® (March 18, 2023)
  • K212905 — Sotair Device (August 18, 2022)
  • K210288 — Disposable Manual Resuscitator (August 26, 2021)
  • K181583 — Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resu (December 7, 2018)
  • K170663 — Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremoun (May 11, 2018)
  • K152931 — Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR (August 29, 2016)
  • K132172 — NEONATALIE RESUSCITATOR (January 15, 2015)
  • K112852 — BABI PLUS NEONATAL RESUSCITATION BAG (January 13, 2012)