The following data is part of a premarket notification filed by Bar - Advanced Control Systems Ltd. with the FDA for Automatic Self-operated Screening Audiometer Device (asam).
| Device ID | K982566 |
| 510k Number | K982566 |
| Device Name: | AUTOMATIC SELF-OPERATED SCREENING AUDIOMETER DEVICE (ASAM) |
| Classification | Audiometer |
| Applicant | BAR - ADVANCED CONTROL SYSTEMS LTD. P.O. BOX 454 Ginot Shomron, IL 44853 |
| Contact | Ahava Stein |
| Correspondent | Ahava Stein BAR - ADVANCED CONTROL SYSTEMS LTD. P.O. BOX 454 Ginot Shomron, IL 44853 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-23 |
| Decision Date | 1998-10-21 |