510(k) K962750
K962750 is an FDA 510(k) premarket notification submitted by Imation Corp. for the device "3M TRIMATIC MODULAR ADVANCED PROCESSING SYSTEM AND 3M APS AUTOMATIC FILM PROCESSOR". The FDA issued a decision of Substantially Equivalent on August 21, 1996. The device falls under product code IXW (Processor, Radiographic-Film, Automatic), a Class II device regulated under 21 CFR 892.1900. Imation Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 21, 1996
- Date Received
- July 15, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Processor, Radiographic-Film, Automatic
- Device Class
- Class II
- Regulation Number
- 892.1900
- Review Panel
- RA
- Submission Type