Duns Number:530120146
Device Description: The Monitor is intended to be used for monitoring, displaying, reviewing, storing and alar The Monitor is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG, Heart Rate(HR), Respiration Rate(RESP), Temperature(TEMP), Oxygen Saturation(BLT-SpO2), Pulse Rate(PR), Non-invasive Blood Pressure(NIBP), Carbon dioxide(CO2) of adult, pediatric and neonatal patient.
Catalog Number
-
Brand Name
Patient Monitor
Version/Model Number
M8500
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K112803
Product Code
MHX
Product Code Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Public Device Record Key
ecc52884-6f0b-4274-9702-bc022ef88837
Public Version Date
November 10, 2021
Public Version Number
6
DI Record Publish Date
September 22, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 35 |