The following data is part of a premarket notification filed by Mini-mitter Co., Inc. with the FDA for Actiware-plms.
| Device ID | K011430 |
| 510k Number | K011430 |
| Device Name: | ACTIWARE-PLMS |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | MINI-MITTER CO., INC. 20300 EMPIRE AVE. BLDG. B-3 Bend, OR 97701 |
| Contact | Jack E Mckenzie |
| Correspondent | Jack E Mckenzie MINI-MITTER CO., INC. 20300 EMPIRE AVE. BLDG. B-3 Bend, OR 97701 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-09 |
| Decision Date | 2001-05-31 |