Duns Number:790605856
Device Description: "SureSigns Central Monitoring System for connectivity to SureSigns VM patient monitors, si "SureSigns Central Monitoring System for connectivity to SureSigns VM patient monitors, single or dual display support Includes PC with software installed, SW CD, license key, speakers, mouse, keyboard optional :printer, switch"
Catalog Number
863291
Brand Name
Philips SureSigns Central
Version/Model Number
Philips SureSigns Central
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"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K131032
Product Code
MHX
Product Code Name
MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
Public Device Record Key
0fedd8c7-aaf8-4418-b6bc-16ff034f341e
Public Version Date
November 01, 2022
Public Version Number
8
DI Record Publish Date
October 03, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 323 |
| 3 | A medical device with high risk that requires premarket approval | 36 |
| U | Unclassified | 1 |