K850644 is an FDA 510(k) clearance for the NASOPHARYNGEAL AIRWAY-ROBERTAZZI. This device is classified as a Airway, Nasopharyngeal (Class I - General Controls, product code BTQ).
Submitted by Dryden Corp. (Indianapolis, US). The FDA issued a Cleared decision on March 21, 1985, 30 days after receiving the submission on February 19, 1985.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5100.
| 510(k) Number | K850644 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 19, 1985 |
| Decision Date | March 21, 1985 |
| Days to Decision | 30 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 |