510(k) K904103
K904103 is an FDA 510(k) premarket notification submitted by Elema-Schonander, Inc. for the device "SEP 90". The FDA issued a decision of Substantially Equivalent on November 20, 1990. The device falls under product code IZP (Programmer, Changer, Film/Cassette, Radiographic), a Class II device regulated under 21 CFR 892.1870. Elema-Schonander, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 20, 1990
- Date Received
- September 6, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Programmer, Changer, Film/Cassette, Radiographic
- Device Class
- Class II
- Regulation Number
- 892.1870
- Review Panel
- RA
- Submission Type