Duns Number:198227881
Device Description: Surveyor Central Review Station - ; English language and CD manual; 110V power; Turnkey sy Surveyor Central Review Station - ; English language and CD manual; 110V power; Turnkey system includes configured CPU with DVD+/-RW drive; No printer; Color LCD 24" monitor with high resolution; VERITAS analysis algorithm with 12-lead ECG interpretation and UNIPRO export; Surveyor Central Review Station - ; English language and CD manual; 110V power; Turnkey system includes configured CPU with DVD+/-RW drive; No printer; Color LCD 24" monitor with high resolution; VERITAS analysis algorithm wit
Catalog Number
SCREV-AAA-AXBAX
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)
-
Over the Counter (OTC)
Yes
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
5837f62a-c23b-40d4-874d-b1df76fb3297
Public Version Date
June 28, 2022
Public Version Number
3
DI Record Publish Date
July 24, 2019
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 |