The following data is part of a premarket notification filed by Hypersound Health, Inc. with the FDA for Hypersound Audio System (hss).
| Device ID | K133352 |
| 510k Number | K133352 |
| Device Name: | HYPERSOUND AUDIO SYSTEM (HSS) |
| Classification | Hearing Aid, Group And Auditory Trainer |
| Applicant | HYPERSOUND HEALTH, INC. 13771 DANIELSON ST. STE. L Poway, CA 92064 |
| Contact | James A Barnes |
| Correspondent | James A Barnes HYPERSOUND HEALTH, INC. 13771 DANIELSON ST. STE. L Poway, CA 92064 |
| Product Code | EPF |
| CFR Regulation Number | 874.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-31 |
| Decision Date | 2014-02-12 |
| Summary: | summary |