K991045 is an FDA 510(k) clearance for the MINI-LOGGER SERIES 2000. This device is classified as a Conditioner, Signal, Physiological (Class II - Special Controls, product code GWK).
Submitted by Mini-Mitter Co., Inc. (Sunriver, US). The FDA issued a Cleared decision on September 21, 1999, 176 days after receiving the submission on March 29, 1999.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1845.
| 510(k) Number | K991045 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 29, 1999 |
| Decision Date | September 21, 1999 |
| Days to Decision | 176 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GWK — Conditioner, Signal, Physiological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1845 |