Clearance Summary
Saalio received FDA 510(k) clearance under submission number K191436, sponsored by Saalmann Medical GmbH & Co. KG. 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 2019-10-18.
- Submission: K191436
- Applicant / Sponsor: Saalmann Medical GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5525
- Decision date: 2019-10-18
Classification & Regulation
This clearance is catalogued under FDA product code EGJ and 21 CFR 890.5525, within the Physical Medicine review panel as a Class II device.