Clearance Summary
RASCAL ANESTHESIA RESPIRATORY GAS ANALYZOR received FDA 510(k) clearance under submission number K855108, sponsored by Biomaterials International, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1986-02-21.
- Submission: K855108
- Applicant / Sponsor: Biomaterials International, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2300
- Decision date: 1986-02-21
Classification & Regulation
This clearance is catalogued under FDA product code JJQ and 21 CFR 862.2300, within the Clinical Chemistry review panel as a Class I device.