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FDA 510(k)

740 SafeSAT

K-Number: K200160 · 2021-02-15

ApplicantZoe Medical, Inc.
Decision Date2021-02-15
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

740 SafeSAT is a medical device manufactured by Zoe Medical, Inc.. It received FDA 510(k) clearance on 2021-02-15 under approval number K200160. 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 740 SafeSAT?

740 SafeSAT is a medical device that received FDA 510(k) clearance on 2021-02-15. It is manufactured by Zoe Medical, Inc.. The 510(k) number is K200160.

When was 740 SafeSAT approved by the FDA?

740 SafeSAT received FDA 510(k) clearance on 2021-02-15, under approval number K200160.

What company makes 740 SafeSAT?

740 SafeSAT is manufactured by Zoe Medical, Inc..

What is the FDA product code for 740 SafeSAT?

The FDA product code for 740 SafeSAT is MWI.

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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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