Catalog Number

-

Brand Name

SweatC

Version/Model Number

A001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K152216

Product Code

GZO

Product Code Name

Device, Galvanic Skin Response Measurement

Public Device Record Key

cc769e94-7643-42e3-99d7-f9c728f238b6

Public Version Date

June 07, 2019

Public Version Number

2

DI Record Publish Date

March 12, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-