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FDA 510(k), K131044, SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION
FDA 510(k), K131044, SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION
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510(K) Number: K131044
Device Name: SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION
Manufacturer: YOLANDA SMITH
Device Classification Name: Stethoscope, Electronic
Regulation Number: DQD
Classification Product Code: 04/15/2013
Date Received: 09/04/2013
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION
Manufacturer: YOLANDA SMITH
Device Classification Name: Stethoscope, Electronic
Regulation Number: DQD
Classification Product Code: 04/15/2013
Date Received: 09/04/2013
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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