The following data is part of a premarket notification filed by Bluemtech with the FDA for Solid Gel Pad.
| Device ID | K131905 |
| 510k Number | K131905 |
| Device Name: | SOLID GEL PAD |
| Classification | Media, Coupling, Ultrasound |
| Applicant | BLUEMTECH 1515 E KATELLA AVE UNIT 2115 Anaheim, CA 92805 |
| Contact | Priscilla Chung |
| Correspondent | Priscilla Chung BLUEMTECH 1515 E KATELLA AVE UNIT 2115 Anaheim, CA 92805 |
| Product Code | MUI |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-26 |
| Decision Date | 2013-07-18 |
| Summary: | summary |