The following data is part of a premarket notification filed by Etrauma.com Corp. with the FDA for Remoteimage System.
| Device ID | K994228 |
| 510k Number | K994228 |
| Device Name: | REMOTEIMAGE SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | ETRAUMA.COM CORP. 1425 EAST NEWPORT CENTER DR. Deerfield Beach, FL 33442 |
| Contact | Dan Hodgeman |
| Correspondent | Dan Hodgeman ETRAUMA.COM CORP. 1425 EAST NEWPORT CENTER DR. Deerfield Beach, FL 33442 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-15 |
| Decision Date | 2000-02-22 |
| Summary: | summary |