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FDA 510(k)

S1

K-Number: K231672 · 2023-10-13

ApplicantMedpark Co., Ltd.
Decision Date2023-10-13
Product CodeNPM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

S1 is a medical device manufactured by Medpark Co., Ltd.. It received FDA 510(k) clearance on 2023-10-13 under approval number K231672. The device is classified under product code NPM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S1?

S1 is a medical device that received FDA 510(k) clearance on 2023-10-13. It is manufactured by Medpark Co., Ltd.. The 510(k) number is K231672.

When was S1 approved by the FDA?

S1 received FDA 510(k) clearance on 2023-10-13, under approval number K231672.

What company makes S1?

S1 is manufactured by Medpark Co., Ltd..

What is the FDA product code for S1?

The FDA product code for S1 is NPM.

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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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