Clearance Summary
ELK LASER IMAGER, MODEL EL-DRY 4000 received FDA 510(k) clearance under submission number K011949, sponsored by Nishimoto Sangyo Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2001-08-29.
- Submission: K011949
- Applicant / Sponsor: Nishimoto Sangyo Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2040
- Decision date: 2001-08-29
Classification & Regulation
This clearance is catalogued under FDA product code LMC and 21 CFR 892.2040, within the Radiology review panel as a Class II device.