K912884 is an FDA 510(k) clearance for the E.T. TAPE II. This device is classified as a Device, Fixation, Tracheal Tube (Class I - General Controls, product code CBH).
Submitted by B&B Medical Technologies, Inc. (Orangevale, US). The FDA issued a Cleared decision on July 31, 1991, 30 days after receiving the submission on July 1, 1991.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5770.
| 510(k) Number | K912884 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 1991 |
| Decision Date | July 31, 1991 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | CBH — Device, Fixation, Tracheal Tube |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5770 |