FDA 510(k)

Spartan SC 069

K-Number: K220716 · 2022-05-05

Decision Date2022-05-05

Product CodeDQY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Spartan SC 069 is the device name listed in this FDA 510(k) record. The listed applicant is Spartan Micro, Inc.. It received FDA 510(k) clearance on 2022-05-05 under 510(k) number K220716. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Spartan SC 069?

Spartan SC 069 is a medical device that received FDA 510(k) clearance on 2022-05-05. The listed applicant is Spartan Micro, Inc.. The 510(k) number is K220716.

When did Spartan SC 069 receive FDA 510(k) clearance?

Spartan SC 069 received FDA 510(k) clearance on 2022-05-05, under 510(k) number K220716.

Who is the listed applicant for Spartan SC 069?

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

What is the FDA product code for Spartan SC 069?

The FDA product code for Spartan SC 069 is DQY.

Other records listing Spartan Micro, Inc. as applicant

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.