K143195 is an FDA 510(k) clearance for the Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1). This device is classified as a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II - Special Controls, product code MHX).
Submitted by Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. (Shenzhen, TW). The FDA issued a Cleared decision on December 22, 2014, 46 days after receiving the submission on November 6, 2014.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K143195 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 06, 2014 |
| Decision Date | December 22, 2014 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MHX - Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1025 |