K940320 is an FDA 510(k) clearance for the AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGS. This device is classified as a Airway, Nasopharyngeal (Class I - General Controls, product code BTQ).
Submitted by Ad-Tech Medical Instrument Corp (Racine, US). The FDA issued a Cleared decision on September 19, 1995, 603 days after receiving the submission on January 24, 1994.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5100.
| 510(k) Number | K940320 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 24, 1994 |
| Decision Date | September 19, 1995 |
| Days to Decision | 603 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 |