The following data is part of a premarket notification filed by Hayashi Denki Co., Ltd. with the FDA for Mini-doppler Es-100.
| Device ID | K840542 |
| 510k Number | K840542 |
| Device Name: | MINI-DOPPLER ES-100 |
| Classification | Transducer, Ultrasonic |
| Applicant | HAYASHI DENKI CO., LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JOP |
| CFR Regulation Number | 870.2880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-08 |
| Decision Date | 1984-07-16 |