The following data is part of a premarket notification filed by Ibramed Equipamentos Medicos with the FDA for Sonopulse Compact 1mhz, Sonopulse Compact 3mhz.
| Device ID | K131309 |
| 510k Number | K131309 |
| Device Name: | SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ |
| Classification | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
| Applicant | IBRAMED EQUIPAMENTOS MEDICOS 18851 NE 29TH AVE 720 Aventura, FL 33180 |
| Contact | Tara Conrad |
| Correspondent | Tara Conrad IBRAMED EQUIPAMENTOS MEDICOS 18851 NE 29TH AVE 720 Aventura, FL 33180 |
| Product Code | IMI |
| CFR Regulation Number | 890.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-07 |
| Decision Date | 2014-01-27 |
| Summary: | summary |