K181286 is an FDA 510(k) clearance for the Ambu aScope RLS 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 November 30, 2018, 198 days after receiving the submission on May 16, 2018.
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 | K181286 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 16, 2018 |
| Decision Date | November 30, 2018 |
| Days to Decision | 198 days |
| Submission Type | Traditional |
| 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). |