K891405 is an FDA 510(k) clearance for the BMS-2000 MOBILE EEG SYSTEM. This device is classified as a Encephalogram Telemetry System (Class II - Special Controls, product code GYE).
Submitted by Buckman Co., Inc. (Martinez, US). The FDA issued a Cleared decision on August 2, 1989, 141 days after receiving the submission on March 14, 1989.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1855.
| 510(k) Number | K891405 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 1989 |
| Decision Date | August 02, 1989 |
| Days to Decision | 141 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | GYE — Encephalogram Telemetry System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1855 |