The following data is part of a premarket notification filed by Medikro Oy with the FDA for Medikro Nano, Medikro Primo And Medikro Pro.
| Device ID | K133428 |
| 510k Number | K133428 |
| Device Name: | MEDIKRO NANO, MEDIKRO PRIMO AND MEDIKRO PRO |
| 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 | 2013-11-08 |
| Decision Date | 2014-05-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06420099000516 | K133428 | 000 |
| 06420099000523 | K133428 | 000 |
| 06420099000509 | K133428 | 000 |
| 06420099000561 | K133428 | 000 |
| 06420099000554 | K133428 | 000 |
| 06420099001087 | K133428 | 000 |