Duns Number:251731105
Device Description: Oral only thermocouple intended for use during sleep disorders studies as a qualitative me Oral only thermocouple intended for use during sleep disorders studies as a qualitative measure of respiratory airflow for recording onto a data acquisition system.
Catalog Number
B1220
Brand Name
BRAEBON Oral Thermocouple Airflow Sensor
Version/Model Number
B1220
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K981445
Product Code
BZQ
Product Code Name
Monitor, Breathing Frequency
Public Device Record Key
f741a577-11b3-40b5-a273-75d9473ef991
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 22, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 112 |