K071564 is an FDA 510(k) clearance for the MOTIVA MONITOR DEVICE CONNECTIVITY, MODEL# 453564036921. This device is classified as a Transmitters And Receivers, Physiological Signal, Radiofrequency (Class II - Special Controls, product code DRG).
Submitted by Philips Medical Systems (Andover, US). The FDA issued a Cleared decision on August 31, 2007, 85 days after receiving the submission on June 7, 2007.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2910.
| 510(k) Number | K071564 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 2007 |
| Decision Date | August 31, 2007 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRG — Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2910 |