The following data is part of a premarket notification filed by Biosearch Medical Products, Inc. with the FDA for Syn-02 Pn Amplifier.
| Device ID | K830421 |
| 510k Number | K830421 |
| Device Name: | SYN-02 PN AMPLIFIER |
| Classification | System, Gastrointestinal Motility (electrical) |
| Applicant | BIOSEARCH MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FFX |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-08 |
| Decision Date | 1983-04-06 |