Clearance Summary
A2J MZ 45 LASER LIGHT FOR POSITIONING received FDA 510(k) clearance under submission number K881591, sponsored by A2j, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1988-04-27.
- Submission: K881591
- Applicant / Sponsor: A2j, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.6500
- Decision date: 1988-04-27
Classification & Regulation
This clearance is catalogued under FDA product code IWX and 21 CFR 892.6500, within the Radiology review panel as a Class I device.