The following data is part of a premarket notification filed by Medinet Srl with the FDA for Medinet Incentive Spirometers - Respiprogram.
| Device ID | K160837 |
| 510k Number | K160837 |
| Device Name: | MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | MEDINET SRL VIA LONDONIO, 12 Milano, IT 20154 |
| Contact | Stefano Bernucci |
| Correspondent | Maurizio Pantaleoni ISEMED SRL VIA A.BONETTI 3/A Imola, IT 40026 |
| Product Code | BWF |
| CFR Regulation Number | 868.5690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-25 |
| Decision Date | 2017-02-23 |
| Summary: | summary |