510(k) K964414
K964414 is an FDA 510(k) premarket notification submitted by Bayer Corp., Agfa Div. for the device "LR 5200 LASER FILM RECORDER". The FDA issued a decision of Substantially Equivalent on January 27, 1997. The device falls under product code LMC (Camera, Multi Format, Radiological), a Class II device regulated under 21 CFR 892.2040. Bayer Corp., Agfa Div. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 27, 1997
- Date Received
- November 5, 1996
- 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