Duns Number:791140622
Device Description: The Maxxi Position Sensor is intended for use with the polysomnograph system to acquire th The Maxxi Position Sensor is intended for use with the polysomnograph system to acquire the body position of adult patients during sleep studies
Catalog Number
SI
Brand Name
Neurovirtual
Version/Model Number
Maxxi Position Sensor
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
Yes
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
K191492
Product Code
LEL
Product Code Name
Device, Sleep Assessment
Public Device Record Key
9037d7f1-05b2-4b23-816a-b3f01dfebae8
Public Version Date
August 14, 2020
Public Version Number
1
DI Record Publish Date
August 06, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 38 |