K944049 is an FDA 510(k) clearance for the OXYGEN MOUTHGUARD. This device is classified as a Endoscopic Bite Block (Class I - General Controls, product code MNK).
Submitted by Endovations, Inc. (Reading, US). The FDA issued a Cleared decision on October 11, 1994, 54 days after receiving the submission on August 18, 1994.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Prevent Patient From Biting Down In Order To Protect Fragile Endoscope Equipment, Patient's Teeth And Gums, And Endscopist's Fingers When Inserting Endoscope Orally..
| 510(k) Number | K944049 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 18, 1994 |
| Decision Date | October 11, 1994 |
| Days to Decision | 54 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | MNK — Endoscopic Bite Block |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Prevent Patient From Biting Down In Order To Protect Fragile Endoscope Equipment, Patient's Teeth And Gums, And Endscopist's Fingers When Inserting Endoscope Orally. |