510(k) K944049
K944049 is an FDA 510(k) premarket notification submitted by Endovations, Inc. for the device "OXYGEN MOUTHGUARD". The FDA issued a decision of Substantially Equivalent on October 11, 1994. The device falls under product code MNK (Endoscopic Bite Block), a Class I device regulated under 21 CFR 876.1500. Endovations, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 11, 1994
- Date Received
- August 18, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscopic Bite Block
- Device Class
- Class I
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
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.