The following data is part of a premarket notification filed by Kelleher Corp. with the FDA for Aural Reflex Indicator.
Device ID | K822566 |
510k Number | K822566 |
Device Name: | AURAL REFLEX INDICATOR |
Classification | Tester, Auditory Impedance |
Applicant | KELLEHER CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ETY |
CFR Regulation Number | 874.1090 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-08-24 |
Decision Date | 1982-09-14 |