The following data is part of a premarket notification filed by Medikro Oy with the FDA for Medikro Spirostar, M929 Medikro Spirostar Usb And M921 Medikro Spirostar Dx.
| Device ID | K120577 |
| 510k Number | K120577 |
| Device Name: | MEDIKRO SPIROSTAR, M929 Medikro Spirostar USB And M921 Medikro SpiroStar DX |
| Classification | Spirometer, Diagnostic |
| Applicant | MEDIKRO OY KELLOLAHDENTIE 27 Kuopio, FI Fi-70460 |
| Contact | Mikko Eloranta |
| Correspondent | Mikko Eloranta MEDIKRO OY KELLOLAHDENTIE 27 Kuopio, FI Fi-70460 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-27 |
| Decision Date | 2015-06-24 |
| Summary: | summary |