Duns Number:184817096
Device Description: KoKo Sx 1000 spirometer and software package. The Standalone Edition is configured to oper KoKo Sx 1000 spirometer and software package. The Standalone Edition is configured to operate on a single computer without access to an Iris central database.
Catalog Number
313120
Brand Name
nSpire Health
Version/Model Number
KoKo Sx 1000 Diagnostic Spirometer Standalone Edition
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
K914272
Product Code
BZG
Product Code Name
Spirometer, Diagnostic
Public Device Record Key
2ecc32cc-8f9a-4e5d-9e5e-f92bd7f7e314
Public Version Date
March 08, 2022
Public Version Number
5
DI Record Publish Date
January 24, 2017
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. | 14 |