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FDA 510(k)

Loop System

K-Number: K181352 · 2019-03-29

ApplicantSpry Health, Inc.
Decision Date2019-03-29
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Loop System is a medical device manufactured by Spry Health, Inc.. It received FDA 510(k) clearance on 2019-03-29 under approval number K181352. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Loop System?

Loop System is a medical device that received FDA 510(k) clearance on 2019-03-29. It is manufactured by Spry Health, Inc.. The 510(k) number is K181352.

When was Loop System approved by the FDA?

Loop System received FDA 510(k) clearance on 2019-03-29, under approval number K181352.

What company makes Loop System?

Loop System is manufactured by Spry Health, Inc..

What is the FDA product code for Loop System?

The FDA product code for Loop System is DQA.

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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.

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