The following data is part of a premarket notification filed by Galix Biomedical Instrumentation, Inc. with the FDA for Galix Ecg Professional Station.
| Device ID | K051163 |
| 510k Number | K051163 |
| Device Name: | GALIX ECG PROFESSIONAL STATION |
| Classification | Electrocardiograph |
| Applicant | GALIX BIOMEDICAL INSTRUMENTATION, INC. 2555 COLLINS AVE., C-5 Miami Beach, FL 33140 |
| Contact | Greg Velez |
| Correspondent | Greg Velez GALIX BIOMEDICAL INSTRUMENTATION, INC. 2555 COLLINS AVE., C-5 Miami Beach, FL 33140 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-05 |
| Decision Date | 2006-01-31 |