Duns Number:198227881
Device Description: Surveyor Central Station with S4 Wifi telemetry monitoring capabilities; English language Surveyor Central Station with S4 Wifi telemetry monitoring capabilities; English language and CD manual; Configured CPU (custom SCNODE configuration must be determined) with 220V power and no display monitors; Custom number of hard wired patient monitoring slots and telemetry channels; Redundant server (RAID1+0) storage for up to 1,200 days, no network printer included; VERITAS analysis algorithm with 12- lead ECG interpretation, extended arrhythmia, 12-lead ST segment monitoring, and hemodynam
Catalog Number
SCSYS-HAD-SDFCA
Brand Name
Welch Allyn, Inc.
Version/Model Number
901137
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
-
Product Code
MHX
Product Code Name
MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
Public Device Record Key
af861b21-74aa-41aa-99ec-05594a0a792f
Public Version Date
June 28, 2022
Public Version Number
2
DI Record Publish Date
September 28, 2020
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 | 374 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4080 |
| 3 | A medical device with high risk that requires premarket approval | 1 |