510(k) K911749
K911749 is an FDA 510(k) premarket notification submitted by Montifore Medical Center for the device "L-LINEX-RAY FLUORESCENCE". The FDA issued a decision of Substantially Equivalent on August 20, 1991. The device falls under product code JAO (Scanner, Fluorescent), a Class II device regulated under 21 CFR 892.1220.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 20, 1991
- Date Received
- April 18, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scanner, Fluorescent
- Device Class
- Class II
- Regulation Number
- 892.1220
- Review Panel
- RA
- Submission Type