Data / Medical devices / Sweden / PROTOTAL Sweden AB
PROTOTAL Sweden AB: FDA-registered device maker in Jonkoping, Sweden, 1 510(k) clearance
PROTOTAL Sweden AB is registered with the FDA (registration 3010526986) in Jonkoping, Sweden. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 4, 2007. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010526986
- Address
- Instrumentvaegen 6, Jonkoping, Sweden, 553 02
- Owner or operator
- Prototal Sweden AB (10045504)
- Roles
- Manufacturer
- First device listed
- November 25, 2013
- Registered through
- 2026
- Brand names listed
- Frida Baby, Nose Frida, Oximeter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | 2 | Manufacturer | accessdata.fda.gov |
| Catheters, Suction, Tracheobronchial | BSY | 1 | Manufacturer | accessdata.fda.gov |
| Dilator, Rectal | FFP | 1 | Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 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 |
|---|---|---|---|---|---|---|
| May 4, 2007 | K063752 | LIFESENSE, MODEL LS1-9R | DQA | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheters, Suction, Tracheobronchial
- All makers of Dilator, Rectal
- All makers of Oximeter
- All makers of Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Updated May 4, 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.