Data / Medical devices / Brazil / Philips Clinical Informatics
Philips Clinical Informatics: FDA-registered device maker in Blumenau Santa Catarina, Brazil, 1 510(k) clearance
Philips Clinical Informatics is registered with the FDA (registration 3014128039) in Blumenau Santa Catarina, Brazil. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 26, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014128039
- Address
- Rua 2 de Setembro 1944 - Itoupava Norte, Blumenau Santa Catarina, Brazil, 89052004
- Owner or operator
- Philips Medical Systems International BV (1217116)
- Roles
- Manufacturer
- First device listed
- June 29, 2011
- Registered through
- 2026
- Brand names listed
- Xper Flex Cardio Physiomonitoring System, Xper Information Management System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | 2 | Manufacturer | accessdata.fda.gov |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| October 26, 2010 | K101571 | XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMS | MWI | Substantially Equivalent | Witt Biomedical Corp | accessdata.fda.gov |
Compare with other makers
- All makers of Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- All makers of Computer, Diagnostic, Programmable
Updated October 26, 2010. 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.