K844478Substantially Equivalent
Hearing Aids Models Ims, Isd, Icl & Ihx
The Ite Co., Seal Beach CA / Traditional, Substantially Equivalent
K844478 is the FDA 510(k) clearance record for HEARING AIDS MODELS IMS, ISD, ICL & IHX, cleared for The Ite Co. on . FDA records list one 510(k) clearance for The Ite Co. As of , FDA records show no recalls naming K844478.
Clearance record
- Decision date
- Received
- (101 days to decision)
- Review panel
- Unknown
- Applicant
- The Ite Co. P.O. Box 2665, Seal Beach CA
- Third party review
- No
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.