Duns Number:341467978
Device Description: This flexible fibre scope is designed with the flexible insertion tube with its bendable d This flexible fibre scope is designed with the flexible insertion tube with its bendable distal tip, the handle with the leakage tester and connection for light source port. The handle incorporates the control lever to bend the distal tip. The picture is the region under examination is imaged by an optical unit.
Catalog Number
-
Brand Name
Laryngoskop FS2
Version/Model Number
1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
9e034905-89b0-4974-b931-5d834f662cca
Public Version Date
October 27, 2020
Public Version Number
1
DI Record Publish Date
October 19, 2020
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 |