Clearance Summary
DERMTRODE received FDA 510(k) clearance under submission number K883869, sponsored by World Precision Instruments, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1988-09-30.
- Submission: K883869
- Applicant / Sponsor: World Precision Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class I
- Regulation citation: 21 CFR 882.1410
- Decision date: 1988-09-30
Classification & Regulation
This clearance is catalogued under FDA product code GYA and 21 CFR 882.1410, within the Neurology review panel as a Class I device.