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FDA 510(k)

TempTraq

K-Number: K201977 · 2020-12-03

ApplicantBlue Spark Technologies, Inc.
Decision Date2020-12-03
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TempTraq is a medical device manufactured by Blue Spark Technologies, Inc.. It received FDA 510(k) clearance on 2020-12-03 under approval number K201977. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TempTraq?

TempTraq is a medical device that received FDA 510(k) clearance on 2020-12-03. It is manufactured by Blue Spark Technologies, Inc.. The 510(k) number is K201977.

When was TempTraq approved by the FDA?

TempTraq received FDA 510(k) clearance on 2020-12-03, under approval number K201977.

What company makes TempTraq?

TempTraq is manufactured by Blue Spark Technologies, Inc..

What is the FDA product code for TempTraq?

The FDA product code for TempTraq is FLL.

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Official Source

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