K860949 is an FDA 510(k) clearance for the DUAL-AID. This device is classified as a Airway, Oropharyngeal, Anesthesiology (Class I - General Controls, product code CAE).
Submitted by Vitalograph , Ltd. (Lenexa, US). The FDA issued a Cleared decision on May 6, 1986, 55 days after receiving the submission on March 12, 1986.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5110.
| 510(k) Number | K860949 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 12, 1986 |
| Decision Date | May 06, 1986 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | - |
| Product Code | CAE - Airway, Oropharyngeal, Anesthesiology |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5110 |