Globalcardio
FDA 510(k) K111320 · Cardiocomm Solutions, Inc.
510(k) numberK111320
Submission
- Device name
- Globalcardio
- Applicant
- Cardiocomm Solutions, Inc.
Appollo Beach, FL, US - Received
- May 10, 2011
- Decision date
- October 7, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DSH – Recorder, Magnetic Tape, Medical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2800
- Specialty
- Cardiovascular
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More from Bardy Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K181310 | HeartCheck Cardi Beat ECG Monitor with GEMS MobileDXH · Traditional | 02/22/2019SE |
| K122632 | Guava IIDPS · Traditional | 02/11/2014SE |
| K121009 | Heartcheck ECG Pen with Gems HomeDPS · Traditional | 05/17/2012SE |
| K111159 | Heartcheck Pen Handheld ECG with Gems HomeDPS · Traditional | 12/22/2011SE |
| K033037 | Modification to GlobalcardioDSH · Traditional | 10/31/2003SE |
| K022297 | Global ECG Management System (Gems)DSH · Special | 09/27/2002SE |
| K020366 | Global ECG Management System (Gems)DPS · Traditional | 04/30/2002SE |
| K013354 | GlobalcardioDSH · Traditional | 01/31/2002SE |
Questions and answers
When was Globalcardio cleared by the FDA?
Globalcardio (K111320) received a 510(k) decision of Substantially Equivalent on October 7, 2011, 150 days after the submission was received.
What is the product code of K111320?
The FDA product code is DSH – Recorder, Magnetic Tape, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2800.