510(k) K841431
K841431 is an FDA 510(k) premarket notification submitted by The Allen Products Co. for the device "RADIOGRAPHIC FILM PROCESSOR M-30CR &". The FDA issued a decision of Substantially Equivalent on July 6, 1984. The device falls under product code IXX (Processor, Cine Film), a Class II device regulated under 21 CFR 892.1900. The Allen Products Co. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 6, 1984
- Date Received
- April 6, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Processor, Cine Film
- Device Class
- Class II
- Regulation Number
- 892.1900
- Review Panel
- RA
- Submission Type