Philips Polska Sp. z o.o.

FDA Device Registration & Listing · Lodz Lodzkie, PL · Registration 3038281851

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3038281851
FEI Number
3038281851
Entity Name
Philips Polska Sp. z o.o.
City/State/Country
Lodz Lodzkie, PL
Establishment Address
Pilsudskiego 88, Lodz Lodzkie 92-202, PL
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Philips Medical Systems International BV (Owner Number: 1217116)
Owner / Operator Contact Address
Veenpluis 6, Best, NL-NOTA 5684PC, NL
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K072286
PMA Number
N/A

All Registered Proprietary Names

453564561901 M_BIS OEM BIS LoC 4-CH Device PWR Link 451261003621 M_BIS BISx Power Link ROHS 453564453711 M_BIS BISx Power Link

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OLT Non-Normalizing Quantitative Electroencephalograph Software Neurology Class 2 882.1400 2025-04-23
OMC Reduced- Montage Standard Electroencephalograph Neurology Class 2 882.1400 2025-04-23
OLW Index-Generating Electroencephalograph Software Neurology Class 2 882.1400 2025-04-23
ORT Burst Suppression Detection Software For Electroencephalograph Neurology Class 2 882.1400 2025-04-23

Official Correspondent

No official correspondent registered.

US Agent Details

Martin Pedroza Business: PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV Email: martin.pedroza@philips.com Phone: (440) 2197243

Related Public Records

Same Entity

Philips Medical Systems International BV
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3003584029 Braemar Manufacturing, LLC San Diego, CA, US
3042175841 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Best Noord-Brabant, NL
3008514395 Telcare, LLC Linwood, PA, US
3004961434 RESPIRATORY TECHNOLOGIES, INC. Plymouth, MN, US
3008773647 CARDIONET, LLC Phoenix, AZ, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K033010 Brainz Instruments , Ltd. BRM2 BRAIN MONITOR 2003-10-10
K991012 Siemens Medical Solutions USA, Inc. SIEMENS INFINITY EEG POD 1999-06-24
K852587 Tracor Northern, Inc. CDSA(COLOR DENSITY, SPECTRAL ARRRAY) 1985-08-16

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3009156722 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. Shenzhen Guangdong, CN
3016674095 Industrial Vallera de Mexicali, S.A. de C.V. (Terra) Mexicali Baja California, MX
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038281851. Last updated year: 2026. Please use registration number 3038281851 when referencing this establishment in official correspondence.
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