The following data is part of a premarket notification filed by Kw Ear Lab, Inc with the FDA for Reve134.
| Device ID | K151719 |
| 510k Number | K151719 |
| Device Name: | REVE134 |
| Classification | Masker, Tinnitus |
| Applicant | KW EAR LAB, INC 18655 South Bishop Ave Carson, CA 90746 |
| Contact | Sungwoo Cho |
| Correspondent | Sungwoo Cho KW EAR LAB, INC 18655 South Bishop Ave Carson, CA 90746 |
| Product Code | KLW |
| CFR Regulation Number | 874.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-25 |
| Decision Date | 2015-10-09 |
| Summary: | summary |