Duns Number:058614483
Device Description: Bedside Respiratory Patient Monitoring System DSPM1000N
Catalog Number
-
Brand Name
Nellcor
Version/Model Number
DSPM1000N
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 28, 2019
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K141518
Product Code
DQA
Product Code Name
Oximeter
Public Device Record Key
496cf864-ebc5-4aad-9dcd-674939de09b8
Public Version Date
August 31, 2022
Public Version Number
7
DI Record Publish Date
July 21, 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 | 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 |