The following data is part of a premarket notification filed by Brymill Corp. with the FDA for Brymascan-a.
| Device ID | K881336 |
| 510k Number | K881336 |
| Device Name: | BRYMASCAN-A |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | BRYMILL CORP. P.O. BOX 2392 Vernon, CT 06066 |
| Contact | Michael D Bryne |
| Correspondent | Michael D Bryne BRYMILL CORP. P.O. BOX 2392 Vernon, CT 06066 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-29 |
| Decision Date | 1989-03-14 |