Duns Number:438896136
Device Description: The COSMED Spiropalm pulmonary function testing systems are spirometers for performing the The COSMED Spiropalm pulmonary function testing systems are spirometers for performing the basic lung function tests (basic spirometry: Forced Vital Capacity, Slow Vital Capacity, Maximum Voluntary Ventilation) and Pulse Oximetry tests on population from 4-6 years old to older population in the physician's office or a hospital setting.
Catalog Number
-
Brand Name
COSMED
Version/Model Number
Spiropalm
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
K093174
Product Code
BZG
Product Code Name
Spirometer, Diagnostic
Public Device Record Key
e3a18fd4-c7ab-4b06-b6f9-bfb3753d05d0
Public Version Date
March 08, 2022
Public Version Number
5
DI Record Publish Date
September 23, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |