Submission Details
| 510(k) Number | K183387 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 06, 2018 |
| Decision Date | August 06, 2019 |
| Days to Decision | 243 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
M3290B Patient Information Center iX
Aug 2019
Decision
243d
Days
Class 2
Risk
About This 510(k) Submission
K183387 is an FDA 510(k) clearance for the M3290B Patient 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 August 6, 2019, 243 days after receiving the submission on December 6, 2018. 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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