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.
| Device ID | K971670 |
| 510k Number | K971670 |
| Device Name: | 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | GALIX BIOMEDICAL INSTRUMENTATION, INC. 2555 COLLINS AVE., C-5 Miami Beach, FL 33140 |
| Contact | Jordan Gavrielides |
| Correspondent | Jordan Gavrielides GALIX BIOMEDICAL INSTRUMENTATION, INC. 2555 COLLINS AVE., C-5 Miami Beach, FL 33140 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-06 |
| Decision Date | 1998-01-29 |