510(k) K915088
K915088 is an FDA 510(k) premarket notification submitted by Eastman Kodak Company for the device "KODAK MIN-R IDENTIFICATION CAMERA". The FDA issued a decision of Substantially Equivalent on December 2, 1991. The device falls under product code JAC (System, X-Ray, Film Marking, Radiographic), a Class I device regulated under 21 CFR 892.1640. Eastman Kodak Company has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 2, 1991
- Date Received
- November 12, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Film Marking, Radiographic
- Device Class
- Class I
- Regulation Number
- 892.1640
- Review Panel
- RA
- Submission Type