Clearance Summary
PB 254 IR - SPECTROMETER received FDA 510(k) clearance under submission number K861213, sponsored by Datex Division Instrumentarium Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1986-04-04.
- Submission: K861213
- Applicant / Sponsor: Datex Division Instrumentarium Corp.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1400
- Decision date: 1986-04-04
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.