The following data is part of a premarket notification filed by Efilm Medical, Inc. with the FDA for Efilm Video.
| Device ID | K013631 |
| 510k Number | K013631 |
| Device Name: | EFILM VIDEO |
| Classification | Digitizer, Image, Radiological |
| Applicant | EFILM MEDICAL, INC. 500 UNIVERSITY AVE., SUITE 300 Toronto, Ontario, CA M5g 1v7 |
| Contact | Joseph A Thomas |
| Correspondent | N.e. Devine Jr. ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | LMA |
| CFR Regulation Number | 892.2030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-11-05 |
| Decision Date | 2001-11-20 |
| Summary: | summary |