Data / Medical devices / Poland / Philips Polska Sp. z o.o.
Philips Polska Sp. z o.o.: FDA-registered device maker in Lodz Lodzkie, Poland, 1 510(k) clearance
Philips Polska Sp. z o.o. is registered with the FDA (registration 3038281851) in Lodz Lodzkie, Poland. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 20, 2007. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3038281851
- Address
- Pilsudskiego 88, Lodz Lodzkie, Poland, 92-202
- Owner or operator
- Philips Medical Systems International BV (1217116)
- Roles
- Exporter to the US
- First device listed
- April 23, 2025
- Registered through
- 2026
- Brand names listed
- 451261003621 M_BIS BISx Power Link ROHS, 453564453711 M_BIS BISx Power Link, 453564561901 M_BIS OEM BIS LoC 4-CH Device PWR Link
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Burst Suppression Detection Software For Electroencephalograph | ORT | 2 | Exporter to the US | accessdata.fda.gov |
| Index-Generating Electroencephalograph Software | OLW | 2 | Exporter to the US | accessdata.fda.gov |
| Non-Normalizing Quantitative Electroencephalograph Software | OLT | 2 | Exporter to the US | accessdata.fda.gov |
| Reduced- Montage Standard Electroencephalograph | OMC | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 20, 2007 | K072286 | BIS EEG VISTA MONITOR SYSTEM AND BISX | OLW | Substantially Equivalent | Aspect Medical Systems, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Reduced- Montage Standard Electroencephalograph
- All makers of Non-Normalizing Quantitative Electroencephalograph Software
- All makers of Index-Generating Electroencephalograph Software
- All makers of Burst Suppression Detection Software For Electroencephalograph
Updated November 20, 2007. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.