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FDA 510(k)

Stasis Monitoring System

K-Number: K183634 · 2019-04-17

ApplicantStasis Labs, Inc.
Decision Date2019-04-17
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Stasis Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Stasis Labs, Inc.. It received FDA 510(k) clearance on 2019-04-17 under 510(k) number K183634. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stasis Monitoring System?

Stasis Monitoring System is a medical device that received FDA 510(k) clearance on 2019-04-17. The listed applicant is Stasis Labs, Inc.. The 510(k) number is K183634.

When did Stasis Monitoring System receive FDA 510(k) clearance?

Stasis Monitoring System received FDA 510(k) clearance on 2019-04-17, under 510(k) number K183634.

Who is the listed applicant for Stasis Monitoring System?

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

What is the FDA product code for Stasis Monitoring System?

The FDA product code for Stasis Monitoring System is MWI.

Related Devices (Code: MWI)

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

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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