Clearance Summary
NASAL/ORAL 02 DELIVERY AND GAS SAMPLING DEVICE received FDA 510(k) clearance under submission number K911970, sponsored by Nasorcap Ent., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1992-08-14.
- Submission: K911970
- Applicant / Sponsor: Nasorcap Ent., Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1400
- Decision date: 1992-08-14
Classification & Regulation
This clearance is catalogued under FDA product code CCK and 21 CFR 868.1400, within the Anesthesiology review panel as a Class II device.