K903618 is an FDA 510(k) clearance for the ROBERTAZZI NASOPHARYNGEAL AIRWAY. This device is classified as a Airway, Nasopharyngeal (Class I - General Controls, product code BTQ).
Submitted by Eastmed Enterprises, Inc. (Marlton, US). The FDA issued a Cleared decision on January 8, 1991, 154 days after receiving the submission on August 7, 1990.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5100.
| 510(k) Number | K903618 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 07, 1990 |
| Decision Date | January 08, 1991 |
| Days to Decision | 154 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BTQ — Airway, Nasopharyngeal |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5100 |