The following data is part of a premarket notification filed by Otoharmonics Corp with the FDA for Levo Tinnitus Masking Software Device.
| Device ID | K140845 |
| 510k Number | K140845 |
| Device Name: | LEVO TINNITUS MASKING SOFTWARE DEVICE |
| Classification | Masker, Tinnitus |
| Applicant | OTOHARMONICS CORP 1835 MARKET ST. 29TH FLOOR Philadelphia, PA 19103 |
| Contact | Yarmela Pavlovic |
| Correspondent | Yarmela Pavlovic OTOHARMONICS CORP 1835 MARKET ST. 29TH FLOOR Philadelphia, PA 19103 |
| Product Code | KLW |
| CFR Regulation Number | 874.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-02 |
| Decision Date | 2014-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B400215930 | K140845 | 000 |
| B400215720 | K140845 | 000 |
| G172616890 | K140845 | 000 |
| G172604520 | K140845 | 000 |