AG 100s

FDA 510(k) K180991 · Hospitech Respiration , Ltd.

Substantially Equivalent

510(k) numberK180991

Submission

Device name
AG 100s
Applicant
Hospitech Respiration , Ltd.
Petach Tikva, IL
Received
April 16, 2018
Decision date
October 12, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BSK – Cuff, Tracheal Tube, Inflatable
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5750
Specialty
Anesthesiology
Life-sustaining
Yes

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K220854TrachCuff Cuff ControllerBSK · Traditional Aw Technologies Aps04/14/2023SE
K221477AG100sBSK · Traditional Hospitech Respiration , Ltd.12/29/2022SE
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K191858Pylant MonitorBSK · Traditional Kal-Med, LLC02/24/2020SE
K182548Accucuff Cuff Pressure IndicatorBSK · Traditional Tianjin Medis Medical Device Co., Ltd.01/25/2019SE
K173914VORTRAN Cuff Inflator (VCI)BSK · Traditional Vortran Medical Technology 1, Inc.05/25/2018SE

More from Vortran Medical Technology 1, Inc.

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K221477AG100sBSK · Traditional 12/29/2022SE
K150157AnapnoGuard 100 Respiratory Guard SystemBSK · Traditional 02/16/2016SE
K131099AG MassJCX · Traditional 05/13/2013SE
K122721AG GuffillBSK · Traditional 05/03/2013SE
K093126Anapnoguard Endotracheal TubeBTP · Traditional 03/02/2010SE

Questions and answers

When was AG 100s cleared by the FDA?

AG 100s (K180991) received a 510(k) decision of Substantially Equivalent on October 12, 2018, 179 days after the submission was received.

What is the product code of K180991?

The FDA product code is BSK – Cuff, Tracheal Tube, Inflatable, a Class II (moderate risk) device regulated under 21 CFR 868.5750.