510(k) K881591
K881591 is an FDA 510(k) premarket notification submitted by A2J, Inc. for the device "A2J MZ 45 LASER LIGHT FOR POSITIONING". The FDA issued a decision of Substantially Equivalent on Apr 27, 1988. The device falls under product code IWX (Barrier, Control Panel, X-Ray, Movable), a Class I device regulated under 21 CFR 892.6500. A2J, Inc. has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 27, 1988
- Date Received
- Apr 13, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Barrier, Control Panel, X-Ray, Movable
- Device Class
- Class I
- Regulation Number
- 892.6500
- Review Panel
- RA
- Submission Type
- 510(k) Exempt