Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Bronchoscope (Flexible Or Rigid)
510(k) Number K161656
FOIA Releasable 510(k) K161656
Device Name 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
Applicant
Ambu A/S
Baltorpbakken 13
Ballerup,  DK DK-2750
Applicant Contact CAMILLA WISMAR
Correspondent
Ambu, Inc.
6230 Old Dobbin Ln. Suite 250
Columbia,  MD  21045
Correspondent Contact SANJAY PARIKH
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received06/16/2016
Decision Date 09/01/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-