K191080 is an FDA 510(k) clearance for the Ambu aScope 4 RhinoLaryngo Slim. This device is classified as a Nasopharyngoscope (flexible Or Rigid) (Class II - Special Controls, product code EOB).
Submitted by Ambu A/S (Ballerup, DK). The FDA issued a Cleared decision on May 22, 2019, 28 days after receiving the submission on April 24, 2019.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4760. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf)..
| 510(k) Number | K191080 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 24, 2019 |
| Decision Date | May 22, 2019 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | EOB — Nasopharyngoscope (flexible Or Rigid) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.4760 |
| Definition | If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf). |