The following data is part of a premarket notification filed by Ivt Medical Ltd with the FDA for Vcare A.
| Device ID | K121817 |
| 510k Number | K121817 |
| Device Name: | VCARE A |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | IVT MEDICAL LTD POB 6718 Efrat, IL 91435 |
| Contact | Eli Orbach |
| Correspondent | Eli Orbach IVT MEDICAL LTD POB 6718 Efrat, IL 91435 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-20 |
| Decision Date | 2013-09-17 |
| Summary: | summary |