The following data is part of a premarket notification filed by Carilex Medical, Inc. with the FDA for Vt·one, Vt·one 60days.
| Device ID | K161410 |
| 510k Number | K161410 |
| Device Name: | VT·One, VT·One 60days |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | CARILEX MEDICAL, INC. No. 77, Keji 1st Rd., Guishan Dist. Taoyuan City, TW 333 |
| Contact | Henry Kao |
| Correspondent | Maria Griffin MDI CONSULTANTS, INC. 55 NORTHERN BLVD. Great Neck, NY 11021 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-20 |
| Decision Date | 2016-10-13 |
| Summary: | summary |