FDA 510(k)

Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach)

Номер K: K241311 · 2024-08-02

Дата решения2024-08-02

Код продуктаMQC

РешениеSubstantially Equivalent

Описание устройства

Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach) is the device name listed in this FDA 510(k) record. The listed applicant is Bernhard Förster GmbH. It received FDA 510(k) clearance on 2024-08-02 under 510(k) number K241311. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach)?

Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach) is a medical device that received FDA 510(k) clearance on 2024-08-02. The listed applicant is Bernhard Förster GmbH. The 510(k) number is K241311.

When did Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach) receive FDA 510(k) clearance?

Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach) received FDA 510(k) clearance on 2024-08-02, under 510(k) number K241311.

Who is the listed applicant for Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach)?

The FDA 510(k) record lists Bernhard Förster GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach)?

The FDA product code for Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach) is MQC.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: MQC)

K253798UltraPrint-Dental Hard Splint UVGuangzhou Heygears IMC., Inc.K250743Remvia NightGuardRemvia K251252NOBILCAM IMPAK DiscShandong Huge Dental Material Corporation K241729Hard Splint & Thermo-Adaptive SplintWhip Mix Corporation K243516Remi Custom Night GuardGrindguard, Inc.K241369LIJIA Night GuardLijia, LLC

Официальный источник

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