510(k) K973422
K973422 is an FDA 510(k) premarket notification submitted by Dejarnette Research Systems for the device "LASERSHARE PRINT SPOOLER(2100[SOLARIS X86]/(1500[WINDOWS NT])". The FDA issued a decision of Substantially Equivalent on Oct 28, 1997. The device falls under product code LMC (Camera, Multi Format, Radiological), a Class II device regulated under 21 CFR 892.2040. Dejarnette Research Systems has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 28, 1997
- Date Received
- Sep 10, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Multi Format, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2040
- Review Panel
- RA
- Submission Type