Duns Number:198227881
Device Description: Welch Allyn Spot Vital Signs Device with Masimo SpO2, Non-invasive Blood Pressure, Pulse R Welch Allyn Spot Vital Signs Device with Masimo SpO2, Non-invasive Blood Pressure, Pulse Rate, MAP; 120 V, 60 Hz AC, Lithium Ion (#105631) Battery; IEC Plug Type-B
Catalog Number
42M0B-E1
Brand Name
Welch Allyn, Inc.
Version/Model Number
901057
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
K101680
Product Code
DQA
Product Code Name
Oximeter
Public Device Record Key
63ecbd1a-0731-421a-925b-af0f6fd83b2b
Public Version Date
September 22, 2020
Public Version Number
7
DI Record Publish Date
December 05, 2017
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 |