FDA 510(k)

BOSS

K-Number: K253723 · 2026-06-16

Decision Date2026-06-16

Product CodeNPM

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

BOSS is the device name listed in this FDA 510(k) record. The listed applicant is Medpark Co., Ltd.. It received FDA 510(k) clearance on 2026-06-16 under 510(k) number K253723. 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 BOSS?

BOSS is a medical device that received FDA 510(k) clearance on 2026-06-16. The listed applicant is Medpark Co., Ltd.. The 510(k) number is K253723.

When did BOSS receive FDA 510(k) clearance?

BOSS received FDA 510(k) clearance on 2026-06-16, under 510(k) number K253723.

Who is the listed applicant for BOSS?

The FDA 510(k) record lists Medpark Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BOSS?

The FDA product code for BOSS is NPM.

Other records listing Medpark Co., Ltd. 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.

K231672S1

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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.