Clearance Summary
ASTOTHERM PLUS, ASTOTUBES, ASTOLINE received FDA 510(k) clearance under submission number K991160, sponsored by Stihler Electronic GmbH. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1999-09-02.
- Submission: K991160
- Applicant / Sponsor: Stihler Electronic GmbH
- Clearance pathway: Abbreviated
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.9205
- Decision date: 1999-09-02
Classification & Regulation
This clearance is catalogued under FDA product code BSB and 21 CFR 864.9205, within the Hematology review panel as a Class II device.