FDA 510(k) Applications Submitted by AMBU A/S
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K193095 |
11/07/2019 |
Ambu aScope 4 Cysto |
Ambu A/S |
| K160766 |
03/21/2016 |
Ambu USR, Ambu M |
AMBU A/S |
| K181286 |
05/16/2018 |
Ambu aScope RLS Slim |
Ambu A/S |
| K161656 |
06/16/2016 |
Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Ambu aView Monitor |
AMBU A/S |
| K232582 |
08/25/2023 |
Ambu« aScopeÖ 5 Broncho 4.2/2.2 Sampler Set |
Ambu A/S |
| K220606 |
03/02/2022 |
Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2 |
Ambu A/S |
| K210883 |
03/25/2021 |
aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8 |
Ambu A/S |
| K190972 |
04/15/2019 |
Ambu aScope 4 RhinoLaryngo Intervention |
Ambu A/S |
| K191080 |
04/24/2019 |
Ambu aScope 4 RhinoLaryngo Slim |
Ambu A/S |
| K230428 |
02/17/2023 |
Ambu« aScopeÖ 5 Broncho 2.7/1.2, Ambu« aScopeÖ 5 Broncho 4.2/2.2, Ambu« aBoxÖ 2 |
Ambu A/S |
| K203749 |
12/23/2020 |
Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable |
Ambu A/S |
| K223782 |
12/16/2022 |
Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set |
Ambu A/S |
| K152931 |
10/05/2015 |
Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator |
AMBU A/S |
| K223299 |
10/27/2022 |
Ambu« aScopeÖ 5 Broncho HD 5.0/2.2, Ambu« aScopeÖ 5 Broncho HD 5.6/2.8, Ambu« aViewÖ 2 Advance |
Ambu A/S |
| K173727 |
12/05/2017 |
Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor |
Ambu A/S |
| K230332 |
02/07/2023 |
Ambu« aScopeÖ Colon; Ambu« aBoxÖ 2 |
Ambu A/S |
| K212382 |
08/02/2021 |
Ambu« aScopeÖ Gastro, Ambu« aBoxÖ2 |
Ambu A/S |
| K100129 |
01/19/2010 |
AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X |
AMBU A/S |
| K130845 |
03/26/2013 |
AMBU ASCOPE 3 5.0/2.2; AMBU ASCOPE 3 SLIM 3.8/1.2; AMBU AVIEW |
AMBU A/S |
| K110962 |
04/06/2011 |
AMBU ASCOPE 2 |
AMBU A/S |
| K071185 |
04/30/2007 |
MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE |
AMBU A/S |
| K071186 |
04/30/2007 |
MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE |
AMBU A/S |
| K102824 |
09/29/2010 |
AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC |
AMBU A/S |
| K093186 |
10/09/2009 |
AMBU ASCOPE AND MONITOR |
AMBU A/S |
| K052944 |
10/20/2005 |
AMBU WHITE SENSOR CFM, CFL |
AMBU A/S |
| K053140 |
11/09/2005 |
AMBU MARK IV RESUSCITATOR |
AMBU A/S |
| K053142 |
11/09/2005 |
AMBU MARK IV BABY RESUSCITATOR |
AMBU A/S |
| K093825 |
12/14/2009 |
AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE |
AMBU A/S |
| K053550 |
12/20/2005 |
AMBU BLUE SENSOR NEO AND NEO X |
AMBU A/S |
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