K061870 is an FDA 510(k) clearance for the VITALSENSE XHR. 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 August 31, 2006, 59 days after receiving the submission on July 3, 2006.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1845.
| 510(k) Number | K061870 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 03, 2006 |
| Decision Date | August 31, 2006 |
| Days to Decision | 59 days |
| Submission Type | Special |
| 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 |