Submission Details
| 510(k) Number | K161164 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 25, 2016 |
| Decision Date | June 24, 2016 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
CareEvent inclusive of the CareEvent Mobile Application accessory
Jun 2016
Decision
60d
Days
Class 2
Risk
About This 510(k) Submission
K161164 is an FDA 510(k) clearance for the CareEvent inclusive of the CareEvent Mobile Application accessory, a System, Network And Communication, Physiological Monitors (Class II — Special Controls, product code MSX), submitted by Philips Medical Systems (Andover, US). The FDA issued a Cleared decision on June 24, 2016, 60 days after receiving the submission on April 25, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.
Device Classification
| Product Code | MSX — System, Network And Communication, Physiological Monitors |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.2300 |
Manufacturer
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