The following data is part of a premarket notification filed by Benson Medical Instruments Co. with the FDA for Cca-100 (modified).
| Device ID | K963681 |
| 510k Number | K963681 |
| Device Name: | CCA-100 (MODIFIED) |
| 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 | 1996-07-11 |
| Decision Date | 1996-10-08 |