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FDA 510(k), K143114, Sense4Baby System Model B+ (MSA)
FDA 510(k), K143114, Sense4Baby System Model B+ (MSA)
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510(K) Number: K143114
Device Name: Sense4Baby System Model B+ (MSA)
Manufacturer: AIRSTRIP TECHNOLOGIES, INC.
Device Classification Name: Home Uterine Activity Monitor
Regulation Number: 884.2730
Classification Product Code: LQK
Date Received: 10/30/2014
Decision Date: 03/10/2015
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: Sense4Baby System Model B+ (MSA)
Manufacturer: AIRSTRIP TECHNOLOGIES, INC.
Device Classification Name: Home Uterine Activity Monitor
Regulation Number: 884.2730
Classification Product Code: LQK
Date Received: 10/30/2014
Decision Date: 03/10/2015
Regulation Medical Specialty: Obstetrics/Gynecology
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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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