Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

IntelliSpace Perinatal Rev.K.00

K-Number: K173941 · 2018-09-10

ApplicantPhilips Medizin Systeme Boeblingen GmbH
Decision Date2018-09-10
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

IntelliSpace Perinatal Rev.K.00 is a medical device manufactured by Philips Medizin Systeme Boeblingen GmbH. It received FDA 510(k) clearance on 2018-09-10 under approval number K173941. The device is classified under product code HGM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IntelliSpace Perinatal Rev.K.00?

IntelliSpace Perinatal Rev.K.00 is a medical device that received FDA 510(k) clearance on 2018-09-10. It is manufactured by Philips Medizin Systeme Boeblingen GmbH. The 510(k) number is K173941.

When was IntelliSpace Perinatal Rev.K.00 approved by the FDA?

IntelliSpace Perinatal Rev.K.00 received FDA 510(k) clearance on 2018-09-10, under approval number K173941.

What company makes IntelliSpace Perinatal Rev.K.00?

IntelliSpace Perinatal Rev.K.00 is manufactured by Philips Medizin Systeme Boeblingen GmbH.

What is the FDA product code for IntelliSpace Perinatal Rev.K.00?

The FDA product code for IntelliSpace Perinatal Rev.K.00 is HGM.

Other Devices by Philips Medizin Systeme Boeblingen GmbH

K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60; IntelliVue Patient Monitors MP70, MP80, MP90;IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX600;IntelliVue Patient Monitors MX700, MX800 K172904IntelliVue Capnography Extension, IntelliVue Microstream Extension K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable K161767Philips IntelliVue GuardianSoftware K181831IntelliVue Multi-Measurement Module MMX K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension

View all 20 devices →

Related Devices (Code: HGM)

K153580Central Monitoring SystemGuangdong Biolight Meditech Co., Ltd. K171178Central Monitoring SystemEdan Instruments, Inc. K171865F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer MonitoringFarus, LLC K161902Meridian M110 Fetal Monitoring SystemMindchild Medical K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3Edan Instruments, Inc. K173715AlertWatch:OBAlertwatch, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑