Emergiency Resuscitator/Inhalor W/Aspir.

FDA 510(k) K800456 · Khi, Inc.

Substantially Equivalent

510(k) numberK800456

Submission

Device name
Emergiency Resuscitator/Inhalor W/Aspir.
Applicant
Khi, Inc.
Walker, MI, US
Received
February 29, 1980
Decision date
March 18, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
BTL – Ventilator, Emergency, Powered (Resuscitator)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5925
Specialty
Anesthesiology
Life-sustaining
Yes

Other 510(k)s with product code BTL

510(k)DeviceApplicantDecision
K242769VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)BTL · Traditional Draegerwerk AG & CO Kgaa04/04/2025SE
K221634Oxymag - Transport and Emergency VentilatorBTL · Traditional Magnamed Tecnologia Medica S/A05/24/2023SE
K202219VORTRAN GO2VENT with PEEP ValveBTL · Traditional Vortran Medical Technology 1, Inc.02/11/2021SE
K193191MEDUMAT Easy CPR, MEDUMAT Easy CPR with bagBTL · Traditional Weinmann Emergency Medical Technology GmbH + Co.…11/20/2020SE
K182956Puffin Lite Infant Resuscitation SystemBTL · Special International Biomedical01/18/2019SE
K173373SafeT T-Piece ResuscitatorBTL · Traditional Ventlab, LLC11/16/2018SE
K161420Moves SLCBTL · Traditional Thornhill Research, Inc.06/06/2017SE
K162968Vortran GO2VENTBTL · Traditional Vortran Medical Technology 1, Inc.04/10/2017SE
K141595O-Two E700,O-TWO E600,O-TWO E500BTL · Traditional O-Two Medical Technologies, Inc.03/16/2015SE
K142096T-Piece ResuscitatorBTL · Traditional Mercury Medical10/17/2014SE

More from Mercury Medical

510(k)DeviceDecision
K830404Rad ValveBTL · Traditional 03/17/1983SE
K830399Coupling/ValveBTC · Traditional 03/10/1983SE
K811858Khi Cpram Breathing CircuitCAI · Traditional 07/16/1981SE

Questions and answers

When was Emergiency Resuscitator/Inhalor W/Aspir. cleared by the FDA?

Emergiency Resuscitator/Inhalor W/Aspir. (K800456) received a 510(k) decision of Substantially Equivalent on March 18, 1980, 18 days after the submission was received.

What is the product code of K800456?

The FDA product code is BTL – Ventilator, Emergency, Powered (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5925.