The following data is part of a premarket notification filed by Kiro Robotics S.l. with the FDA for Kiro Set.
| Device ID | K152441 |
| 510k Number | K152441 |
| Device Name: | KIRO Set |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | KIRO ROBOTICS S.L. POLO DE INNOVACION GARAIA GOIRU KALEA 1 EDIFICIO B, PISO 2 Arrasate-mondragon, ES 20500 |
| Contact | Naiara Telleria |
| Correspondent | Korina Akhondzadeh KARA & ASSOCIATES, INC 6965 EL CAMINO REAL SUITE 105- 428 Carlsbad, CA 92009 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-27 |
| Decision Date | 2015-12-04 |
| Summary: | summary |