K180991 is an FDA 510(k) clearance for the AG 100s. This device is classified as a Cuff, Tracheal Tube, Inflatable (Class II - Special Controls, product code BSK).
Submitted by Hospitech Respiration , Ltd. (Petach Tikva, IL). The FDA issued a Cleared decision on October 12, 2018, 179 days after receiving the submission on April 16, 2018.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5750.
| 510(k) Number | K180991 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 16, 2018 |
| Decision Date | October 12, 2018 |
| Days to Decision | 179 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BSK - Cuff, Tracheal Tube, Inflatable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5750 |