Clearance Summary
Pobling MIITY 2 received FDA 510(k) clearance under submission number K163550, sponsored by Habalan Med & Beauty Co.,Ltd. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2017-12-20.
- Submission: K163550
- Applicant / Sponsor: Habalan Med & Beauty Co.,Ltd
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2017-12-20
Classification & Regulation
This clearance is catalogued under FDA product code NFO and 21 CFR 882.5890, within the Neurology review panel as a Class II device.