The following data is part of a premarket notification filed by Mini-mitter Co., Inc. with the FDA for Actiwatch-score.
| Device ID | K991033 |
| 510k Number | K991033 |
| Device Name: | ACTIWATCH-SCORE |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | MINI-MITTER CO., INC. PO BOX 3386 Sunriver, OR 97707 |
| Contact | Jack E Mckenzie |
| Correspondent | Jack E Mckenzie MINI-MITTER CO., INC. PO BOX 3386 Sunriver, OR 97707 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-29 |
| Decision Date | 1999-06-23 |
| Summary: | summary |