The following data is part of a premarket notification filed by Benson Medical Instruments Co. with the FDA for Cca-200.
Device ID | K981439 |
510k Number | K981439 |
Device Name: | CCA-200 |
Classification | Audiometer |
Applicant | BENSON MEDICAL INSTRUMENTS CO. 2344 NICOLLET AVE. SOUTH, #150 Minneapolis, MN 55404 |
Contact | David P Mayou |
Correspondent | David P Mayou BENSON MEDICAL INSTRUMENTS CO. 2344 NICOLLET AVE. SOUTH, #150 Minneapolis, MN 55404 |
Product Code | EWO |
CFR Regulation Number | 874.1050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-04-21 |
Decision Date | 1998-06-15 |