Home / 510(k) Clearances / K973106

510(k) K973106

GOLEMB DISPOSABLE BAG MASK RESUSCITATOR by Allied Healthcare Products, Inc. — Product Code BTM

K973106 is an FDA 510(k) premarket notification submitted by Allied Healthcare Products, Inc. for the device "GOLEMB DISPOSABLE BAG MASK RESUSCITATOR". The FDA issued a decision of Substantially Equivalent on January 29, 1998. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915. Allied Healthcare Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 1998
Date Received
August 19, 1997
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 Allied Healthcare Products, Inc.

  • K131098 — EMERGENCY PORTABLE VENTILATOR (April 9, 2014)
  • K132021 — AHP 300, EMERGENCY PORTABLE VENTILATOR (April 2, 2014)
  • K090356 — EMERGENCY PORTABLE VENTILATOR, MODEL EPV200 (May 20, 2009)
  • K083507 — BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS (May 18, 2009)
  • K083385 — MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B (May 14, 2009)
  • K080063 — MASS CASUALTY VENTILATOR, MODEL MCV100 (August 15, 2008)
  • K072214 — PORTABLE VENTILATOR, MODEL EPV-100 (March 6, 2008)
  • K073171 — RESUSCITATION TIMER, MODEL L770-CPR (January 31, 2008)
  • K070636 — AUTOVENT 4000 WITH CPAP (July 13, 2007)
  • K070120 — AUTOVENT MODEL 4000 (May 3, 2007)

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)

FDA data resources