K911784 is an FDA 510(k) clearance for the NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY. This device is classified as a Airway, Nasopharyngeal (Class I - General Controls, product code BTQ).
Submitted by North American Sterilization & Packaging Co. (Sparta, US). The FDA issued a Cleared decision on September 23, 1991, 154 days after receiving the submission on April 22, 1991.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5100.
| 510(k) Number | K911784 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 22, 1991 |
| Decision Date | September 23, 1991 |
| Days to Decision | 154 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BTQ — Airway, Nasopharyngeal |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5100 |