510(k) K840389
K840389 is an FDA 510(k) premarket notification submitted by Elema-Schonander, Inc. for the device "SEP PROGRAMMER SEP-M/SINGLE-PLANE &". The FDA issued a decision of Substantially Equivalent on February 21, 1984. 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
- February 21, 1984
- Date Received
- January 30, 1984
- 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