The following data is part of a premarket notification filed by Cardiocomm Solutions, Inc. with the FDA for Globalcardio.
Device ID | K111320 |
510k Number | K111320 |
Device Name: | GLOBALCARDIO |
Classification | Recorder, Magnetic Tape, Medical |
Applicant | CARDIOCOMM SOLUTIONS, INC. 962 ALLEGRO LANE Apollo Beach, FL 33572 |
Contact | Jon Ward |
Correspondent | Jon Ward CARDIOCOMM SOLUTIONS, INC. 962 ALLEGRO LANE Apollo Beach, FL 33572 |
Product Code | DSH |
CFR Regulation Number | 870.2800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-05-10 |
Decision Date | 2011-10-07 |
Summary: | summary |