The following data is part of a premarket notification filed by Wr Medical Electronics Co. with the FDA for Brackmann Emg Monitoring System.
| Device ID | K895838 |
| 510k Number | K895838 |
| Device Name: | BRACKMANN EMG MONITORING SYSTEM |
| Classification | Stimulator, Nerve |
| Applicant | WR MEDICAL ELECTRONICS CO. 123 NO.2ND.STREET Stillwater, MN 55082 |
| Contact | Patrick J Anderson |
| Correspondent | Patrick J Anderson WR MEDICAL ELECTRONICS CO. 123 NO.2ND.STREET Stillwater, MN 55082 |
| Product Code | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-02 |
| Decision Date | 1990-03-27 |