BPMS Evolution BCE53151

GUDID B970BCE531510

Includes 1 Evolution Handle, BPMS Clinical Software CD with Sensor Map corresponding to Sensor 5315, Help File and PDF of System Manual, System Carrying Case, Sensor Carrying Case, (2) 5315 Sensors with Sensor Cover, and 1 Web-Based Training Session (USA Only)

Tekscan, Inc.

Pressure measurement/mapping system, anatomical
Primary Device IDB970BCE531510
NIH Device Record Keydaadd4fc-16b5-40dd-bd39-3acb49bd915f
Commercial Distribution StatusIn Commercial Distribution
Brand NameBPMS Evolution
Version Model NumberBPMS 1 System (5315 Sensors)
Catalog NumberBCE53151
Company DUNS178180246
Company NameTekscan, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB970BCE531510 [Primary]

FDA Product Code

JFCSystem, Pressure Measurement, Intermittent

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-22
Device Publish Date2020-10-14

Devices Manufactured by Tekscan, Inc.

B970FG2PRO0 - F-Scan GO2024-03-22 Includes 2 TekDAQ 200 Wi-Fi Wearable Sensor Acquisition Units, FootVIEW 10.0 Pro In-Shoe Pressure Measurement Software, 2 Velcro
B970FG20 - F-Scan GO2024-03-11 Includes 2 TekDAQ 200 Wi-Fi Wearable Sensor Acquisition Units, FootVIEW 10.0 In-Shoe Pressure Measurement Software, 2 Velcro Ank
B970TD2000 - TekDAQ 2002024-03-11 TekDAQ 200 Wearable Sensor Data Acquisition Device
B97030101250 - F-Scan GO 3010 Sensor2023-12-07 3010, Matrix Sensor, 125psi
B970BCE531510 - BPMS Evolution2020-10-22Includes 1 Evolution Handle, BPMS Clinical Software CD with Sensor Map corresponding to Sensor 5315, Help File and PDF of System Manual, System Carrying Case, Sensor Carrying Case, (2) 5315 Sensors with Sensor Cover, and 1 Web-Based Training Session (USA Only)
B970BCE531510 - BPMS Evolution2020-10-22 Includes 1 Evolution Handle, BPMS Clinical Software CD with Sensor Map corresponding to Sensor 5315, Help File and PDF of System

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.