The following data is part of a premarket notification filed by Ambu A/s with the FDA for Ambu Ascope Rls Slim.
Device ID | K181286 |
510k Number | K181286 |
Device Name: | Ambu AScope RLS Slim |
Classification | Nasopharyngoscope (flexible Or Rigid) |
Applicant | Ambu A/S Baltorpbakken 13 Ballerup, DK 2750 |
Contact | Camilla Wismar |
Correspondent | Sanjay Parikh Ambu Inc. 6230 Old Dobbin Lane, Suite 250 Columbia, MD 21045 |
Product Code | EOB |
CFR Regulation Number | 874.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-05-16 |
Decision Date | 2018-11-30 |
Summary: | summary |