Submission Details
| 510(k) Number | K142935 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 09, 2014 |
| Decision Date | January 15, 2015 |
| Days to Decision | 98 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
CareEvent
Jan 2015
Decision
98d
Days
Class 2
Risk
About This 510(k) Submission
K142935 is an FDA 510(k) clearance for the CareEvent, 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 January 15, 2015, 98 days after receiving the submission on October 9, 2014. 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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