K853162 is an FDA 510(k) clearance for the STERILE NASOPHARYNGEAL AIRWAY. This device is classified as a Airway, Nasopharyngeal (Class I - General Controls, product code BTQ).
Submitted by Inmed Corp. (Norcross, US). The FDA issued a Cleared decision on August 6, 1985, 7 days after receiving the submission on July 30, 1985.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5100.
| 510(k) Number | K853162 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 30, 1985 |
| Decision Date | August 06, 1985 |
| Days to Decision | 7 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 |