510(k) K012941
K012941 is an FDA 510(k) premarket notification submitted by Agfa Corp. for the device "DRYSTAR, MODEL 4500M". The FDA issued a decision of Substantially Equivalent on November 29, 2001. The device falls under product code LMC (Camera, Multi Format, Radiological), a Class II device regulated under 21 CFR 892.2040. Agfa Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 29, 2001
- Date Received
- August 31, 2001
- 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