Duns Number:071829634
Device Description: STRAIN GAUGE AND PHOTO PLETHYSMOGRAPH; 100V - A mains powered plethysmograph instrument. T STRAIN GAUGE AND PHOTO PLETHYSMOGRAPH; 100V - A mains powered plethysmograph instrument. The user can select between strain gauge and photo plethysmography modes. An analog meter on the front of the instrument indicates the signal level and is calibrated in % Volume Change for strain gauge applications. The plethysmograph signal is also available via analog and digital outputs, to a separate recording device.
Catalog Number
00537
Brand Name
Hokanson
Version/Model Number
EC6
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K982707
Product Code
JOM
Product Code Name
Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Public Device Record Key
07db6324-93dd-4fe2-bedb-68a03e328a29
Public Version Date
October 05, 2020
Public Version Number
4
DI Record Publish Date
September 09, 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. | 218 |