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 | K022297 |
| 510k Number | K022297 |
| Device Name: | GLOBAL ECG MANAGEMENT SYSTEM (GEMS) |
| Classification | Recorder, Magnetic Tape, Medical |
| 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 | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-16 |
| Decision Date | 2002-09-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812324000266 | K022297 | 000 |
| 00812324000228 | K022297 | 000 |
| 00812324000259 | K022297 | 000 |
| 00812324000242 | K022297 | 000 |
| 00812324000211 | K022297 | 000 |
| 00812324000204 | K022297 | 000 |