Ambu A/S - FDA 510(k) Cleared Devices

Cleared Mar 28, 2018

Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2

K173727 · EOQ

Ear, Nose, Throat · 113d

Cleared Sep 01, 2016

Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3...

K161656 · EOQ

Ear, Nose, Throat · 77d

Cleared Aug 29, 2016

Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu...

K152931 · BTM

Anesthesiology · 329d

Cleared Aug 17, 2016

Ambu USR, Ambu M

K160766 · FAJ

Gastroenterology & Urology · 149d

Cleared Nov 01, 2013

AMBU ASCOPE 3 5.0/2.2

K130845 · EOQ

Ear, Nose, Throat · 220d

Cleared Nov 18, 2011

AMBU ASCOPE 2

K110962 · BTR

Anesthesiology · 226d

Cleared Jan 28, 2011

AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC

K102824 · BTM

Anesthesiology · 121d

Cleared Jun 11, 2010

AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X

K100129 · DRX

Cardiovascular · 143d

Cleared Apr 16, 2010

AMBU ASCOPE AND MONITOR

K093186 · BTR

Anesthesiology · 189d

Cleared Jan 13, 2010

AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE

K093825 · IKT

Neurology · 30d

Cleared Jul 30, 2007

MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE

K071186 · IKT

Neurology · 91d

Cleared May 30, 2007

MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE

K071185 · GXZ

Neurology · 30d

Cleared Oct 25, 2006

AMBU WHITE SENSOR CFM, CFL

K052944 · DRX

Cardiovascular · 370d

Cleared Oct 25, 2006

AMBU BLUE SENSOR NEO AND NEO X

K053550 · DRX

Cardiovascular · 309d

Cleared Dec 23, 2005

AMBU MARK IV RESUSCITATOR

K053140 · BTM

Anesthesiology · 44d

Cleared Dec 20, 2005

AMBU MARK IV BABY RESUSCITATOR

K053142 · BTM

Anesthesiology · 41d