510(k) K013631
K013631 is an FDA 510(k) premarket notification submitted by Efilm Medical, Inc. for the device "EFILM VIDEO". The FDA issued a decision of Substantially Equivalent on November 20, 2001. The device falls under product code LMA (Digitizer, Image, Radiological), a Class II device regulated under 21 CFR 892.2030. Efilm Medical, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 20, 2001
- Date Received
- November 5, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Digitizer, Image, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2030
- Review Panel
- RA
- Submission Type