The following data is part of a premarket notification filed by Galix Biomedical Instrumentation, Inc. with the FDA for Galix Winter.
| Device ID | K030145 |
| 510k Number | K030145 |
| Device Name: | GALIX WINTER |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | GALIX BIOMEDICAL INSTRUMENTATION, INC. 2555 COLLINS AVE., C-5 Miami Beach, FL 33140 |
| Contact | Eduardo Rey |
| Correspondent | Eduardo Rey GALIX BIOMEDICAL INSTRUMENTATION, INC. 2555 COLLINS AVE., C-5 Miami Beach, FL 33140 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-15 |
| Decision Date | 2003-09-17 |