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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 the device name listed in this FDA 510(k) record. The listed applicant is Zoe Medical, Inc.. It received FDA 510(k) clearance on 2021-02-15 under 510(k) 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. The listed applicant is Zoe Medical, Inc.. The 510(k) number is K200160.

When did 740 SafeSAT receive FDA 510(k) clearance?

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

Who is the listed applicant for 740 SafeSAT?

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

What is the FDA product code for 740 SafeSAT?

The FDA product code for 740 SafeSAT 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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