Clearance Summary
C-MAX, C-MAX U1, C-MAX U1 160KG, C-MAX U2, C-MAX U2 160KG, S-MAX, S-MAX AVIATION, S-MAX SELLA, S-MAX SELLA 160KG received FDA 510(k) clearance under submission number K103122, sponsored by Aat Alber Antriebstechnik GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2010-12-30.
- Submission: K103122
- Applicant / Sponsor: Aat Alber Antriebstechnik GmbH
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5150
- Decision date: 2010-12-30
Classification & Regulation
This clearance is catalogued under FDA product code ILK and 21 CFR 890.5150, within the Physical Medicine review panel as a Class II device.