Duns Number:341467978
Device Description: Video Nasopharyngo-laryngoscope
Catalog Number
M205220310101
Brand Name
Laryngoscope
Version/Model Number
RSX USB P
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 28, 2020
Issuing Agency
In HIBCC
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K150248
Product Code
EQN
Product Code Name
Laryngoscope, Nasopharyngoscope
Public Device Record Key
c4c3d625-a641-4154-a5ac-18a8e6188b1a
Public Version Date
March 09, 2020
Public Version Number
2
DI Record Publish Date
November 19, 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 | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 4 |