FDA.report

510(k) K201977

Device
TempTraq
Applicant
Blue Spark Technologies Inc.
510(k) number
K201977
Product code
FLL  
Decision
Substantially Equivalent (SESE)
Decision date
2020-12-03
Date received
2020-07-16
Regulation
880.2910
Classification name
Thermometer, Electronic, Clinical
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
John Gannon
Address
806 Sharon Dr., Suite G Westlake OH US 44145 44145

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
00851203006487TempTraq®BLUE SPARK TECHNOLOGIES, INC.2026-02-26
00851203006470TempTraq®BLUE SPARK TECHNOLOGIES, INC.2026-02-26
00851203006449TempTraq®BLUE SPARK TECHNOLOGIES, INC.2026-02-26
00851203006432TempTraq®BLUE SPARK TECHNOLOGIES, INC.2025-03-05
00851203006388TempTraq®BLUE SPARK TECHNOLOGIES, INC.2025-02-25
00851203006371TempTraq®BLUE SPARK TECHNOLOGIES, INC.2025-02-25
00851203006364TempTraq®BLUE SPARK TECHNOLOGIES, INC.2025-02-25
00851203006050TempTraq®BLUE SPARK TECHNOLOGIES, INC.2020-10-21
00851203006104Cell Therapy 360 Wearable Tech V1BLUE SPARK TECHNOLOGIES, INC.2020-10-21

Legacy Summary

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FDA Review

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