Clearance Summary
NMA 1052 CONSOLE SYSTEM WITH NMA 100 LASER ACCESSORY received FDA 510(k) clearance under submission number K024310, sponsored by Medx Electronics, Inc.. 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 2003-03-24.
- Submission: K024310
- Applicant / Sponsor: Medx Electronics, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5500
- Decision date: 2003-03-24
Classification & Regulation
This clearance is catalogued under FDA product code NHN and 21 CFR 890.5500, within the Physical Medicine review panel as a Class II device.