The following data is part of a premarket notification filed by Panasonic Co. Div. Matsu Elec. Corp. America with the FDA for Hearing Aid Various Models.
Device ID | K821972 |
510k Number | K821972 |
Device Name: | HEARING AID VARIOUS MODELS |
Classification | Hearing Aid, Air Conduction |
Applicant | PANASONIC CO. DIV. MATSU ELEC. CORP. AMERICA 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ESD |
CFR Regulation Number | 874.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-07-02 |
Decision Date | 1982-07-20 |