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FDA 510(k), K132918, SENSE-4BABY SYSTEM
FDA 510(k), K132918, SENSE-4BABY SYSTEM
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510(K) Number: K132918
Device Name: SENSE-4BABY SYSTEM
Manufacturer: SENSE4BABY, INC.
Device Classification Name: system, monitoring, perinatal
Regulation Number: 884.2740
Classification Product Code: HGM
Date Received: 09/17/2013
Decision Date: 11/22/2013
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: SENSE-4BABY SYSTEM
Manufacturer: SENSE4BABY, INC.
Device Classification Name: system, monitoring, perinatal
Regulation Number: 884.2740
Classification Product Code: HGM
Date Received: 09/17/2013
Decision Date: 11/22/2013
Regulation Medical Specialty: Obstetrics/Gynecology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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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