FDA 510(k) Premarket Notification K212208: Philips IntelliVue GuardianSoftware (Rev. E.0X)

Submission Details & Decision

Normalized public record details for 510(k) notification K212208.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K212208

Applicant / Sponsor

Philips Medizin Systeme Boeblingen GmbH

Device Name

Philips IntelliVue GuardianSoftware (Rev. E.0X)

Product Code

DXJ

Decision Date

2021-09-30

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Cardiovascular (CV)

Clearance Type

Traditional

Third Party Flag

Date Received

2021-07-15

Related Establishments / Registrations

Philips North America LLC Registration: 1218950 View Registration
ARTHREX, INC. Registration: 1220246 View Registration
ZOLL MEDICAL CORPORATION Registration: 1220908 View Registration
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES Registration: 1651104 View Registration
St. Jude Medical, Atrial Fibrillation Division, Inc. Registration: 2184149 View Registration
Covidien Registration: 2936999 View Registration
Philips Electronics Ltd Registration: 3000126629 View Registration
GE Medical Systems Information Technologies, Inc. Registration: 3001570235 View Registration
Arthrex GmbH Registration: 3002579136 View Registration
St. Jude Medical, Cardiology Division, Inc. Registration: 3005334138 View Registration
EIZO GmbH Registration: 3006615345 View Registration
CARROT MEDICAL, LLC Registration: 3007540658 View Registration
WIPRO GE HEALTHCARE PRIVATE Ltd. Registration: 3007734888 View Registration
Technical Services for Electronics, Inc. Registration: 3008483389 View Registration
GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V. Registration: 3008729547 View Registration
Arthrex, Inc. Registration: 3010331645 View Registration
TRIBE MEDICAL GROUP Registration: 3010400367 View Registration
GWW Registration: 3010698831 View Registration
Gyrus ACMI, Inc. Registration: 3011050570 View Registration
GE Medical Systems Information Technologies, Inc. Registration: 3012359877 View Registration
Arvato SE Registration: 3013247477 View Registration
Amphenol Cable and Interconnect Technologies Asia Pacific Ltd. Registration: 3013500228 View Registration
Amphenol Medical Technologies (Dongguan) Co., Ltd. Registration: 3013596024 View Registration
Murata Vios, Private Limited Registration: 3015181391 View Registration
Murata Vios, Inc. Registration: 3015328411 View Registration
Philips North America LLC Registration: 3016618143 View Registration
Philips North America LLC Registration: 3016701404 View Registration
Arthrex Distribution Hub EMEA B.V. Registration: 3016851379 View Registration
Medtronic Engineering and Innovation Center (MEIC) Registration: 3018094310 View Registration
Arthrex Australia Pty Ltd. Registration: 3019269298 View Registration
Arthrex New Zealand Limited Registration: 3020704423 View Registration
ZOLL International Holding B.V. Registration: 3029871637 View Registration
GALEMED CORP. Registration: 8043316 View Registration
BRAINLAB SE Registration: 8043933 View Registration
OLYMPUS WINTER & IBE GMBH Registration: 9610773 View Registration
Philips Medizin Systeme Boeblingen GmbH Registration: 9610816 View Registration
LivaNova Deutschland GmbH Registration: 9611109 View Registration
BARCO N.V. Registration: 9613188 View Registration

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This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.