| Primary Device ID | B97030101250 |
| NIH Device Record Key | 6c210a18-30fd-4a8d-9f24-46ac123e1293 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | F-Scan GO 3010 Sensor |
| Version Model Number | 3010-125 |
| Company DUNS | 178180246 |
| Company Name | Tekscan, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B97030101250 [Primary] |
| JFC | System, Pressure Measurement, Intermittent |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-07 |
| Device Publish Date | 2023-11-29 |
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| B970FG20 - F-Scan GO | 2024-03-11 Includes 2 TekDAQ 200 Wi-Fi Wearable Sensor Acquisition Units, FootVIEW 10.0 In-Shoe Pressure Measurement Software, 2 Velcro Ank |
| B970TD2000 - TekDAQ 200 | 2024-03-11 TekDAQ 200 Wearable Sensor Data Acquisition Device |
| B97030101250 - F-Scan GO 3010 Sensor | 2023-12-073010, Matrix Sensor, 125psi |
| B97030101250 - F-Scan GO 3010 Sensor | 2023-12-07 3010, Matrix Sensor, 125psi |
| B970BCE531510 - BPMS Evolution | 2020-10-22 Includes 1 Evolution Handle, BPMS Clinical Software CD with Sensor Map corresponding to Sensor 5315, Help File and PDF of System |