K913216 is an FDA 510(k) clearance for the TRACH T ADAPTER. This device is classified as a Connector, Airway (extension) (Class I - General Controls, product code BZA).
Submitted by Specialty Packaging Producs, Inc. (El Paso, US). The FDA issued a Cleared decision on January 15, 1992, 180 days after receiving the submission on July 19, 1991.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5810.
| 510(k) Number | K913216 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 1991 |
| Decision Date | January 15, 1992 |
| Days to Decision | 180 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BZA — Connector, Airway (extension) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5810 |