Submission Details
| 510(k) Number | K143057 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 24, 2014 |
| Decision Date | December 03, 2014 |
| Days to Decision | 40 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
M3290B Philips IntelliVue Information Center iX
Dec 2014
Decision
40d
Days
Class 2
Risk
About This 510(k) Submission
K143057 is an FDA 510(k) clearance for the M3290B Philips IntelliVue Information Center iX, 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 December 3, 2014, 40 days after receiving the submission on October 24, 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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