Duns Number:058614483
Device Description: N-600x Pulse Oximeter Alarm Management System
Catalog Number
-
Brand Name
Nellcor
Version/Model Number
N600X-1A
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 13, 2016
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
K123581
Product Code
DQA
Product Code Name
Oximeter
Public Device Record Key
78dd69e5-789f-41fc-83ca-0c9c62742497
Public Version Date
October 12, 2022
Public Version Number
4
DI Record Publish Date
October 13, 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 | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |