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FDA 510(k), K122184, ECG CHECK
FDA 510(k), K122184, ECG CHECK
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$89.00 USD
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510(K) Number: K122184
Device Name: ECG CHECK
Manufacturer: CARDIAC DESIGNS, LLC
Device Classification Name: transmitters and receivers, electrocardiograph, telephone
Regulation Number: 870.2920
Classification Product Code: DXH
Date Received: 07/23/2012
Decision Date: 02/14/2013
Regulation Medical Specialty: Cardiovascular
Device Name: ECG CHECK
Manufacturer: CARDIAC DESIGNS, LLC
Device Classification Name: transmitters and receivers, electrocardiograph, telephone
Regulation Number: 870.2920
Classification Product Code: DXH
Date Received: 07/23/2012
Decision Date: 02/14/2013
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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