K052489 is an FDA 510(k) clearance for the ACTIHEART. 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 27, 2005, 15 days after receiving the submission on September 12, 2005.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1845.
| 510(k) Number | K052489 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 12, 2005 |
| Decision Date | September 27, 2005 |
| Days to Decision | 15 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 |