510(k) K914978
K914978 is an FDA 510(k) premarket notification submitted by Stantex Pty , Ltd. for the device "OXYGUARD". The FDA issued a decision of Substantially Equivalent on January 10, 1992. The device falls under product code MNK (Endoscopic Bite Block), a Class I device regulated under 21 CFR 876.1500.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 10, 1992
- Date Received
- November 6, 1991
- 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.