K943847 is an FDA 510(k) clearance for the BOBBIN STYLE VENTURI VENT TUBE. This device is classified as a Tube, Tympanostomy (Class II - Special Controls, product code ETD).
Submitted by Micromed Development Corp. (Clearwater, US). The FDA issued a Cleared decision on September 2, 1994, 29 days after receiving the submission on August 4, 1994.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3880.
| 510(k) Number | K943847 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 1994 |
| Decision Date | September 02, 1994 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | ETD — Tube, Tympanostomy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3880 |