Duns Number:480868538
Device Description: The SPIROVIT SP-250 spirometer is used together with the plastic mouth piece to conduct sl The SPIROVIT SP-250 spirometer is used together with the plastic mouth piece to conduct slow and forced spirometry maneuvers.
Catalog Number
2.200560
Brand Name
SPIROVIT SP-250
Version/Model Number
2.200560
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
-
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
K984031
Product Code
BZG
Product Code Name
Spirometer, Diagnostic
Public Device Record Key
f39b2e5d-f103-441b-b47e-7e78a51b77c2
Public Version Date
March 08, 2022
Public Version Number
5
DI Record Publish Date
September 19, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 93 |