Duns Number:117528917
Device Description: All-digital, tempered glass and metal body plethysmograph features fail-safe automatic rel All-digital, tempered glass and metal body plethysmograph features fail-safe automatic release of the cabin door locking mechanism, patient intercom, and motorized sensor arm, providing superior performance, patient comfort and convienence.
Catalog Number
700971
Brand Name
KoKo, LLC
Version/Model Number
KoKo PX4000 Plethysmograph
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
-
Product Code
CCM
Product Code Name
Plethysmograph, Pressure
Public Device Record Key
16a6b8b8-0a78-4b70-8ced-ac7559ae4be3
Public Version Date
April 26, 2021
Public Version Number
1
DI Record Publish Date
April 16, 2021
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. | 3 |