The following data is part of a premarket notification filed by Ihear Medical, Inc. with the FDA for Iheartest.
| Device ID | K151025 |
| 510k Number | K151025 |
| Device Name: | IHearTest |
| Classification | Audiometer |
| Applicant | IHEAR MEDICAL, INC. 15250 HESPERIAN BLVD, STE #102 San Leandro, CA 94578 |
| Contact | Angela Lee Foreman |
| Correspondent | Angela Lee Foreman IHEAR MEDICAL, INC. 15250 HESPERIAN BLVD, STE #102 San Leandro, CA 94578 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-16 |
| Decision Date | 2015-12-29 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() IHEARTEST 98261359 not registered Live/Pending |
Center for Medical Device Innovations, Inc. 2023-11-08 |
![]() IHEARTEST 88035722 not registered Dead/Abandoned |
iHear Medical, Inc. 2018-07-12 |