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 |