Clearance Summary
HEM-O-SCAN OXYGEN EQUIL. CURVE ANALYZER received FDA 510(k) clearance under submission number K802379, sponsored by American Instrument Co.. 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 1980-10-31.
- Submission: K802379
- Applicant / Sponsor: American Instrument Co.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 1980-10-31
Classification & Regulation
This clearance is catalogued under FDA product code LCH and 21 CFR 862.1660, within the Clinical Chemistry review panel as a Class I device.