FDA PMA

Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated

Номер PMA: P160030 · 2026-09-01

ЗаявительAbbott Diabetes Care, Inc.

Дата решения2026-09-01

Номер PMAP160030

Код продуктаPZE

Класс устройстваКласс 3

Медицинская специализацияU

Консультативный комитетCH

Описание устройства

Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Diabetes Care, Inc.. It received FDA 510(k) clearance on 2026-09-01. The device is classified under product code PZE. It was reviewed by the CH advisory panel.

Часто задаваемые вопросы

What is the Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated?

Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated is a medical device that received FDA 510(k) clearance on 2026-09-01. The listed applicant is Abbott Diabetes Care, Inc..

When did Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated receive FDA 510(k) clearance?

The clearance date for Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated can be found in the official FDA records.

Who is the listed applicant for Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated?

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

What is the FDA product code for Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated?

The FDA product code for Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated is PZE.

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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Официальный источник

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