The following data is part of a premarket notification filed by Nano Vibronix, Inc. with the FDA for Ac Wound Treatment System.
| Device ID | K111949 |
| 510k Number | K111949 |
| Device Name: | AC WOUND TREATMENT SYSTEM |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | NANO VIBRONIX, INC. 1468 HARWELL AVE Crofton, MD 21114 |
| Contact | E J Smith |
| Correspondent | E J Smith NANO VIBRONIX, INC. 1468 HARWELL AVE Crofton, MD 21114 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-08 |
| Decision Date | 2012-06-29 |
| Summary: | summary |