The following data is part of a premarket notification filed by Midwest City Hearing Aid Center with the FDA for Dynamic Eq/class D.
Device ID | K953038 |
510k Number | K953038 |
Device Name: | DYNAMIC EQ/CLASS D |
Classification | Hearing Aid, Air Conduction |
Applicant | MIDWEST CITY HEARING AID CENTER 1401 SOUTH MIDWEST BLVD. Midwest City, OK 73110 |
Contact | Frank Carter |
Correspondent | Frank Carter MIDWEST CITY HEARING AID CENTER 1401 SOUTH MIDWEST BLVD. Midwest City, OK 73110 |
Product Code | ESD |
CFR Regulation Number | 874.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-06-19 |
Decision Date | 1995-07-21 |