MatScan VersaTek - Includes MatScan 3150E Sensor installed in floor - Tekscan, Inc.

Duns Number:178180246

Device Description: Includes MatScan 3150E Sensor installed in floor display with 1 VersaTek Cuff, 1 VersaTek Includes MatScan 3150E Sensor installed in floor display with 1 VersaTek Cuff, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, SportsAT Software CD with MatScan 3150 Sensor Map, Help File and PDF of System Manual, 10 ft. USB Cable, 10 ft. Cuff Cable

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More Product Details

Catalog Number

MV1-SPORTS

Brand Name

MatScan VersaTek

Version/Model Number

MatScan VersaTek Platform with SportsAT Software

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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

-

Product Code Details

Product Code

JFC

Product Code Name

System, Pressure Measurement, Intermittent

Device Record Status

Public Device Record Key

3ad809af-a98d-4633-92b1-33c01e45c601

Public Version Date

November 19, 2020

Public Version Number

2

DI Record Publish Date

November 03, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TEKSCAN, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 199