Data / Medical devices / Finland / Medikro OY
Medikro OY: FDA-registered device maker in Kuopio Pohjois-Savo, Finland, 2 510(k) clearances
Medikro OY is registered with the FDA (registration 3006895489) in Kuopio Pohjois-Savo, Finland. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated June 24, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006895489
- Address
- Pioneerinkatu 3, Kuopio Pohjois-Savo, Finland, FI-70800
- Owner or operator
- Medikro Oy (10047101)
- Roles
- Manufacturer
- First device listed
- June 30, 2014
- Registered through
- 2026
- Brand names listed
- 410027, SPIROMETRY KIT, CP150, 410370, PRESSURE TUBE & HANDLE, SPIRO, 410857, SPIROMETER KIT FOR CONNEX CARDIO, 703417 Disposable Flow Transducers QTY 4, 703418 Disposable Flow Transducers QTY 25, 703419 Disposable Flow Transducers QTY 100, 703552 Spirometer Kit (Serial), 703554 Spirometer Kit (USB) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Spirometer, Diagnostic | BZG | 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 |
|---|---|---|---|---|---|---|
| June 24, 2015 | K120577 | MEDIKRO SPIROSTAR, M929 Medikro Spirostar USB and M921 Medikro SpiroStar DX | BZG | Substantially Equivalent | Medikro OY | accessdata.fda.gov |
| May 21, 2014 | K133428 | MEDIKRO NANO, MEDIKRO PRIMO AND MEDIKRO PRO | BZG | Substantially Equivalent | Medikro OY | accessdata.fda.gov |
Compare with other makers
Updated June 24, 2015. 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.