FDA 510(k) Premarket Notification K182637: Philips IntelliVue XDS Software

Submission Details & Decision

Normalized public record details for 510(k) notification K182637.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K182637

Applicant / Sponsor

Philips Medizin Systeme Boeblingen GmbH

Device Name

Philips IntelliVue XDS Software

Product Code

MSX

Decision Date

2019-04-26

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Cardiovascular (CV)

Clearance Type

Traditional

Third Party Flag

Date Received

2018-09-24

Related Establishments / Registrations

DRE Med Registration: 1000122786 View Registration
Philips North America LLC Registration: 1218950 View Registration
WELCH ALLYN, INC. Registration: 1316463 View Registration
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES Registration: 1651104 View Registration
STRYKER MEDICAL Registration: 1831750 View Registration
Nihon Kohden Digital Health Solutions, LLC. Registration: 2032233 View Registration
NIHON KOHDEN AMERICA, INC. Registration: 2080783 View Registration
NORTECH SYSTEMS, INC. Registration: 2183613 View Registration
MINDRAY DS USA, Inc. Registration: 2221819 View Registration
Philips Electronics Ltd Registration: 3000126629 View Registration
Philips Medical Systems Nederland B.V. Registration: 3000976525 View Registration
DRAEGERWERK AG & CO. KGAA Registration: 3001104093 View Registration
GE Medical Systems Information Technologies, Inc. Registration: 3001570235 View Registration
PULSION MEDICAL SYSTEMS SE Registration: 3003263092 View Registration
EDAN INSTRUMENTS, INC. Registration: 3003971136 View Registration
ActiGraph L.L.C. Registration: 3004091281 View Registration
GE HEALTHCARE Registration: 3004526608 View Registration
InfuSystem Inc. Registration: 3004906872 View Registration
DRAEGER MEDICAL SYSTEMS, INC. Registration: 3005783425 View Registration
AirStrip Technologies, Inc. Registration: 3006104191 View Registration
Creative Foam Corporation dba MT. OLIVE MFG Registration: 3006240053 View Registration
ATHENA GTX Registration: 3007413079 View Registration
Nihon Kohden Tomioka Corporation Nihon Kohden Kawamoto Production Center Registration: 3007481893 View Registration
Shenzhen Mindray Bio-Medical Electronics Co.,LTD Registration: 3007603826 View Registration
Kimball Electronics Poland Sp.z o.o Registration: 3008058135 View Registration
GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V. Registration: 3008729547 View Registration
ASCOM US, INC. Registration: 3008855170 View Registration
ASCOM SWEDEN AB Registration: 3008952681 View Registration
DHL SUPPLY CHAIN (NETHERLANDS) B.V. Registration: 3009077524 View Registration
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. Registration: 3009156722 View Registration
VectraCor, Inc. Registration: 3009443693 View Registration
EDAN Diagnostics, Inc. Registration: 3009499478 View Registration
GlobeStar Systems, Inc Registration: 3009595635 View Registration
SOTERA WIRELESS Registration: 3009673645 View Registration
MASIMO CORPORATION Registration: 3009831876 View Registration
Engineered Medical Systems, LLC Registration: 3009973336 View Registration
Spacelabs Healthcare Inc. Registration: 3010157426 View Registration
GWW Registration: 3010698831 View Registration
MAKAR CONSULTING PTY LTD Registration: 3010703925 View Registration
Wellinks Registration: 3011166598 View Registration
MASIMO CORPORATION Registration: 3011353843 View Registration
Spok, Inc. Plano Division Registration: 3011696573 View Registration
GE Medical Systems Information Technologies, Inc. Registration: 3012359877 View Registration
Philips North America LLC Registration: 3012528160 View Registration
Amphenol Cable and Interconnect Technologies Asia Pacific Ltd. Registration: 3013500228 View Registration
Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology Center Registration: 3013501110 View Registration
Cerner Corporation Registration: 3013546957 View Registration
Amphenol Medical Technologies (Dongguan) Co., Ltd. Registration: 3013596024 View Registration
ORANTECH INC. Registration: 3013783488 View Registration
Hypertec HCM LLC Registration: 3013896610 View Registration
Philips Medical Systems Ltda Registration: 3014541700 View Registration
TAIWAN AULISA MEDICAL DEVICES TECHNOLOGIES, INC. Registration: 3014856521 View Registration
Current Health Ltd Registration: 3015134004 View Registration
ASCOM UMS SRL Registration: 3015173634 View Registration
INTEGO SOFTWARE, LLC D/B/A CRITICAL ALERT Registration: 3015437214 View Registration
SIBEL HEALTH INC. Registration: 3015529350 View Registration
DYNAMIC EMS LTD Registration: 3016595211 View Registration
Philips North America LLC Registration: 3016618143 View Registration
HUMA THERAPEUTICS LIMITED Registration: 3016670256 View Registration
Philips North America LLC Registration: 3016701404 View Registration
Nihon Kohden Corporation - Eastern Japan Logistics Center Registration: 3016852448 View Registration
KEY-TECH SCOTLAND LTD Registration: 3018188848 View Registration
Masimo Corporation Registration: 3019388613 View Registration
CORSANO HEALTH B.V. Registration: 3027510187 View Registration
Corsano Health SA Registration: 3038761440 View Registration
LEONHARD LANG GMBH Registration: 8020045 View Registration
GE HEALTHCARE FINLAND OY Registration: 9610105 View Registration
Philips Medizin Systeme Boeblingen GmbH Registration: 9610816 View Registration
NIHON KOHDEN CORP. Registration: 9611252 View Registration
Draegerwerk AG & Co. KGaA Registration: 9611500 View Registration
VELCROMEX, S.A. DE C.V. Registration: 9680215 View Registration
Nicolay GMBH Registration: 9681377 View Registration

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