Duns Number:533070236
Device Description: The Fingerclip PPG sensor is similar in enclosure to a standard pulse oximeter. It is des The Fingerclip PPG sensor is similar in enclosure to a standard pulse oximeter. It is designed primarily to fit comfortably to the fingers. It measures the photoplethysmograph signals as a reference of blood flow for evaluation of segmental blood pressures or other peripheral vascular diagnosis tests
Catalog Number
-
Brand Name
Fingerclip PPG sensor
Version/Model Number
Fingerclip PPG sensor
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 19, 2020
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
K111416
Product Code
JOP
Product Code Name
Transducer, Ultrasonic
Public Device Record Key
4d829c78-cd78-4902-881b-cf69f74af1b6
Public Version Date
June 29, 2020
Public Version Number
1
DI Record Publish Date
June 19, 2020
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. | 26 |