Clearance Summary
NightWare Kit, Apple iPhone, Apple Watch, Apple iPhone Charging Cable, Apple Watch Charging Cable received FDA 510(k) clearance under submission number DEN200033, sponsored by Nightware, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2020-11-06.
- Submission: DEN200033
- Applicant / Sponsor: Nightware, Inc.
- Clearance pathway: Direct
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5705
- Decision date: 2020-11-06
Classification & Regulation
This clearance is catalogued under FDA product code QMZ and 21 CFR 882.5705, within the Neurology review panel as a Class II device.