510(k) K945858
K945858 is an FDA 510(k) premarket notification submitted by J.P.I. Chicago Co. for the device "X-RAY FILM CASSETTE". The FDA issued a decision of Substantially Equivalent on March 21, 1995. The device falls under product code IXA (Cassette, Radiographic Film), a Class II device regulated under 21 CFR 892.1850. J.P.I. Chicago Co. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 21, 1995
- Date Received
- December 1, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cassette, Radiographic Film
- Device Class
- Class II
- Regulation Number
- 892.1850
- Review Panel
- RA
- Submission Type