Submission Details
| 510(k) Number | K151812 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 02, 2015 |
| Decision Date | January 26, 2016 |
| Days to Decision | 208 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
PATIENT MONITORS VARIOUS MODELS
Jan 2016
Decision
208d
Days
Class 2
Risk
About This 510(k) Submission
K151812 is an FDA 510(k) clearance for the PATIENT MONITORS VARIOUS MODELS, 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 January 26, 2016, 208 days after receiving the submission on July 2, 2015. 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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