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Airbile-100

FDA 510(k)

Class II (US FDA 510(k))

510(k) K250976

by Poskom Co., Ltd.

Identifiers

510(k) Number
K250976 FDA 510(k)
FDA Product Code
IZL FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1720 FDA 510(k)
Regulation Number
892.1720 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Airbile-100 by Poskom Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Poskom Co., Ltd.

Sources (1)

  • FDA 510(k) K250976 24 fields · synced Jun 18, 2026