K060919 is an FDA 510(k) clearance for the ACTICAL. This device is classified as a Conditioner, Signal, Physiological (Class II - Special Controls, product code GWK).
Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on September 22, 2006, 171 days after receiving the submission on April 4, 2006.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1845.
| 510(k) Number | K060919 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 2006 |
| Decision Date | September 22, 2006 |
| Days to Decision | 171 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 |