Instant 20s Indicator
K-Number: K210481 · 2021-12-14
ApplicantTrue Indicating, LLC
Decision Date2021-12-14
Product CodeMTC
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Instant 20s Indicator is a medical device manufactured by True Indicating, LLC. It received FDA 510(k) clearance on 2021-12-14 under approval number K210481. The device is classified under product code MTC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Instant 20s Indicator?
Instant 20s Indicator is a medical device that received FDA 510(k) clearance on 2021-12-14. It is manufactured by True Indicating, LLC. The 510(k) number is K210481.
When was Instant 20s Indicator approved by the FDA?
Instant 20s Indicator received FDA 510(k) clearance on 2021-12-14, under approval number K210481.
What company makes Instant 20s Indicator?
Instant 20s Indicator is manufactured by True Indicating, LLC.
What is the FDA product code for Instant 20s Indicator?
The FDA product code for Instant 20s Indicator is MTC.
Other Devices by True Indicating, LLC
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.