The following data is part of a premarket notification filed by Cardiocomm Solutions, Inc. with the FDA for Global Ecg Management System (gems).
| Device ID | K020366 |
| 510k Number | K020366 |
| Device Name: | GLOBAL ECG MANAGEMENT SYSTEM (GEMS) |
| Classification | Electrocardiograph |
| Applicant | CARDIOCOMM SOLUTIONS, INC. 3060 CEDAR HILL RD., SUITE 201 Victoria, B.c., CA V8t 3j5 |
| Contact | Angela Halwas |
| Correspondent | Angela Halwas CARDIOCOMM SOLUTIONS, INC. 3060 CEDAR HILL RD., SUITE 201 Victoria, B.c., CA V8t 3j5 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-04 |
| Decision Date | 2002-04-30 |
| Summary: | summary |