510(k) K915365
K915365 is an FDA 510(k) premarket notification submitted by The Allen Products Co. for the device "AP-6CR CINERADIOGRAPHIC FILM PROCESSOR". The FDA issued a decision of Substantially Equivalent on August 27, 1992. 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
- August 27, 1992
- Date Received
- November 27, 1991
- 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