The following data is part of a premarket notification filed by American Scientific Products with the FDA for B4182-1.
| Device ID | K820533 |
| 510k Number | K820533 |
| Device Name: | B4182-1 |
| Classification | Fibrometer |
| Applicant | AMERICAN SCIENTIFIC PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GIE |
| CFR Regulation Number | 864.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-02 |
| Decision Date | 1982-04-08 |