FDA 510(k)

Stasis Monitoring System

K-Number: K183634 · 2019-04-17

Decision Date2019-04-17

Product CodeMWI

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Stasis Monitoring System is a medical device manufactured by Stasis Labs, Inc.. It received FDA 510(k) clearance on 2019-04-17 under approval 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. It is manufactured by Stasis Labs, Inc.. The 510(k) number is K183634.

When was Stasis Monitoring System approved by the FDA?

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

What company makes Stasis Monitoring System?

Stasis Monitoring System is manufactured by Stasis Labs, Inc..

What is the FDA product code for Stasis Monitoring System?

The FDA product code for Stasis Monitoring System is MWI.

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Related PubMed Literature

PMID: 37181834 Methodology for Conducting Post-Marketing Surveillance of Software as a Medical Device Based on Artificial Intelligence Technologies. Sovremennye tekhnologii v meditsine (2022)

Related Devices (Code: MWI)

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Official Source

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