The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Bms-2000 Mobile Eeg System.
| Device ID | K891405 |
| 510k Number | K891405 |
| Device Name: | BMS-2000 MOBILE EEG SYSTEM |
| Classification | Encephalogram Telemetry System |
| Applicant | BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
| Product Code | GYE |
| CFR Regulation Number | 882.1855 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-14 |
| Decision Date | 1989-08-02 |