Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)— 510(k) K143195
Substantially EquivalentShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.
FDA 510(k) clearance K143195 for Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1), Substantially Equivalent on 2014-12-22. Applicant: Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.
- Product code
- Code MHX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, TW
Recent devices under product code MHX
view allMore clearances from Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.
view all- K221267 — VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor
- K222754 — ViewMate Multi Ultrasound System
- K202785 — Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9 Pro,Nuewa R9S,Resona 7,Resona 7CV,Resona 7EXP,Resona 7S, Resona 7OB,Resona 7PRO,Imagyn 7,Resona Y Diagnostic Ultrasound System
- K173369 — DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System
- K171233 — Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System
Adverse events under product code MHX
product code MHX- Death
- 580
- Injury
- 2,441
- Malfunction
- 12,655
- Other
- 3
- Total
- 15,679
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K143195
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K143195.
Data sourced from openFDA. This site is unofficial and independent of the FDA.