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 |