The following data is part of a premarket notification filed by Cardiocomm Solutions, Inc. with the FDA for Globalcardio.
Device ID | K013354 |
510k Number | K013354 |
Device Name: | GLOBALCARDIO |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-10-09 |
Decision Date | 2002-01-31 |
Summary: | summary |