The following data is part of a premarket notification filed by Efilm Medical, Inc. with the FDA for Efilm Workstation With Modules.
| Device ID | K020995 |
| 510k Number | K020995 |
| Device Name: | EFILM WORKSTATION WITH MODULES |
| Classification | System, Image Processing, Radiological |
| Applicant | EFILM MEDICAL, INC. 500 UNIVERSITY AVE., SUITE 300 Toronto, Ontario, CA M5g 1v7 |
| Contact | Joseph A Thomas |
| Correspondent | Neil E Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-03-28 |
| Decision Date | 2002-04-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842000100287 | K020995 | 000 |
| 00842000100850 | K020995 | 000 |