Submission Details
| 510(k) Number | K163584 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 20, 2016 |
| Decision Date | July 07, 2017 |
| Days to Decision | 199 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
M3290B Philips IntelliVue Information Center iX
Jul 2017
Decision
199d
Days
Class 2
Risk
About This 510(k) Submission
K163584 is an FDA 510(k) clearance for the M3290B Philips IntelliVue Information Center iX, a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX), submitted by Philips Medical Systems (Andover, US). The FDA issued a Cleared decision on July 7, 2017, 199 days after receiving the submission on December 20, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.
Device Classification
| Product Code | MHX — Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1025 |
Manufacturer
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