FDA 510(k), K173941, IntelliSpace Perinatal Rev.K.00
FDA 510(k), K173941, IntelliSpace Perinatal Rev.K.00
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510(K) Number: K173941
Device Name: IntelliSpace Perinatal Rev.K.00
Manufacturer: Philips Medizin Systeme Boeblingen GmbH
Device Classification Name: System, Monitoring, Perinatal
Regulation Number: 884.2740
Classification Product Code: HGM
Date Received: 12/26/2017
Decision Date: 09/10/2018
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: IntelliSpace Perinatal Rev.K.00
Manufacturer: Philips Medizin Systeme Boeblingen GmbH
Device Classification Name: System, Monitoring, Perinatal
Regulation Number: 884.2740
Classification Product Code: HGM
Date Received: 12/26/2017
Decision Date: 09/10/2018
Regulation Medical Specialty: Obstetrics/Gynecology
- 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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