The following data is part of a premarket notification filed by Galix Biomedical Instrumentation, Inc. with the FDA for Galix Pacestar.
| Device ID | K023080 |
| 510k Number | K023080 |
| Device Name: | GALIX PACESTAR |
| Classification | Pulse-generator, Pacemaker, External |
| 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 | DTE |
| CFR Regulation Number | 870.3600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-17 |
| Decision Date | 2003-06-11 |