The following data is part of a premarket notification filed by Bio-feedback Systems, Inc. with the FDA for Multi-channel Isolation Amplifier (mcia).
| Device ID | K900063 |
| 510k Number | K900063 |
| Device Name: | MULTI-CHANNEL ISOLATION AMPLIFIER (MCIA) |
| Classification | Amplifier, Physiological Signal |
| Applicant | BIO-FEEDBACK SYSTEMS, INC. 2736 47TH ST. Boulder, CO 80301 |
| Product Code | GWL |
| CFR Regulation Number | 882.1835 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-03 |
| Decision Date | 1990-02-16 |