The following data is part of a premarket notification filed by Sensus Healthcare, Inc with the FDA for Sensus Healthcare Tvm Balloon Applicator.
| Device ID | K190255 |
| 510k Number | K190255 |
| Device Name: | Sensus Healthcare TVM Balloon Applicator |
| Classification | System, Therapeutic, X-ray |
| Applicant | Sensus Healthcare, Inc 851 Broken Sound Parkway NW, Suite 215 Boca Raton, FL 33487 |
| Contact | Nicolas Soro |
| Correspondent | Nicolas Soro Sensus Healthcare, Inc 851 Broken Sound Parkway NW, Suite 215 Boca Raton, FL 33487 |
| Product Code | JAD |
| CFR Regulation Number | 892.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-07 |
| Decision Date | 2019-02-21 |
| Summary: | summary |