F-Scan VersaTek Wireless Datalogger - Includes 2 VersaTek Cuffs, 1 VersaTek - Tekscan, Inc.

Duns Number:178180246

Device Description: Includes 2 VersaTek Cuffs, 1 VersaTek Wireless/Datalogger Unit with Battery Pack Holder an Includes 2 VersaTek Cuffs, 1 VersaTek Wireless/Datalogger Unit with Battery Pack Holder and Belt, Power Supply and AC Cord, F-Scan Clinical Software CD with F-Scan Map, Help File, PDF of System Manual, Pre-configured wireless router, Formatted Memory Stick, Li-Ion Battery Pack, Battery Pack Charger and Battery Pack Charger Power Supply, 6.5 ft. Mini A/B USB Cable, Trigger Switch, (2) 4 ft. Cuff Cables, Elastic Take-Up Belt, Elastic Belt Extension, 2 Arm/Leg Straps, 2 Velcro Cable Ties, 2 Velcro Wrist/Ankle Bands, Sensor Carrying Case, System Carrying Case, Quick Start Guide, and 1 Training Session (USA Only). System includes one of the following Sensor selections: (20) F-Scan 3000-E, (16) 3000SPORT-E, (14) 3001-E, -or- (12) 3001SPORT-E.

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More Product Details

Catalog Number

FVWD2

Brand Name

F-Scan VersaTek Wireless Datalogger

Version/Model Number

F-Scan VersaTek Wireless/ Datalogger System

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

5b10ced3-2c73-4bd4-b46a-6c55c10c0a9c

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