Clearance Summary
INNOSAN TRAVELAIR S PLUS PORTABLE OXYGEN CONCENTRATOR, CODE NO. M407001853 (WITH AC POWER SUPPLY ACCESSORY) received FDA 510(k) clearance under submission number K971947, sponsored by Sim Italia S.R.L.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1997-10-03.
- Submission: K971947
- Applicant / Sponsor: Sim Italia S.R.L.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5440
- Decision date: 1997-10-03
Classification & Regulation
This clearance is catalogued under FDA product code CAW and 21 CFR 868.5440, within the Anesthesiology review panel as a Class II device.