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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 the device name listed in this FDA 510(k) record. The listed applicant is Spry Health, Inc.. It received FDA 510(k) clearance on 2019-03-29 under 510(k) 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. The listed applicant is Spry Health, Inc.. The 510(k) number is K181352.

When did Loop System receive FDA 510(k) clearance?

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

Who is the listed applicant for Loop System?

The FDA 510(k) record lists Spry Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Loop System?

The FDA product code for Loop System is DQA.

Related Devices (Code: DQA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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