The following data is part of a premarket notification filed by Galix Biomedical Instrumentation, Inc. with the FDA for 3 Channel Digital Ambulatory Ecg Recorder Model Galix Gbi-3sm.
| Device ID | K092853 |
| 510k Number | K092853 |
| Device Name: | 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM |
| Classification | Electrocardiograph, Ambulatory, With Analysis Algorithm |
| Applicant | GALIX BIOMEDICAL INSTRUMENTATION, INC. 2555 COLLINS AVE., C-5 Miami Beach, FL 33140 |
| Contact | Yoel Palomino |
| Correspondent | Yoel Palomino GALIX BIOMEDICAL INSTRUMENTATION, INC. 2555 COLLINS AVE., C-5 Miami Beach, FL 33140 |
| Product Code | MLO |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2009-09-16 |
| Decision Date | 2010-07-09 |