Duns Number:318498177
Device Description: The SpiroScout SP plus is intended exclusively for use with the following SCHILLER devices The SpiroScout SP plus is intended exclusively for use with the following SCHILLER devices. CARDIOVIT CS-104 SPIROVIT SP-1 G2 CARDIOVIT AT-102 G2The SpiroScout SP plus is an ultrasonic measuring system which is used for pulmonary function diagnostics. It determines the transit times of the ultrasonic signals and can be used with the above-mentioned Schiller devices to measure and analyse respiratory flow and volume.
Catalog Number
013400563
Brand Name
SpiroScout SP plus
Version/Model Number
Rev.D
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
K160116
Product Code
BZG
Product Code Name
Spirometer, Diagnostic
Public Device Record Key
dd73f5eb-f1bc-428f-bfe7-901e4230490b
Public Version Date
March 08, 2022
Public Version Number
2
DI Record Publish Date
December 20, 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 |
|---|---|---|
| 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. | 3 |