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FDA 510(k)

Bloom2 Programmable Electrophysiology Stimulator

Número K: K173439 · 2018-03-29

RequerenteFischer Medical
Data da decisão2018-03-29
Código do produtoJOQ
Comité consultivoCV
DecisãoSubstantially Equivalent

Resumo do dispositivo

Bloom2 Programmable Electrophysiology Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Fischer Medical. It received FDA 510(k) clearance on 2018-03-29 under 510(k) number K173439. The device is classified under product code JOQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Bloom2 Programmable Electrophysiology Stimulator?

Bloom2 Programmable Electrophysiology Stimulator is a medical device that received FDA 510(k) clearance on 2018-03-29. The listed applicant is Fischer Medical. The 510(k) number is K173439.

When did Bloom2 Programmable Electrophysiology Stimulator receive FDA 510(k) clearance?

Bloom2 Programmable Electrophysiology Stimulator received FDA 510(k) clearance on 2018-03-29, under 510(k) number K173439.

Who is the listed applicant for Bloom2 Programmable Electrophysiology Stimulator?

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

What is the FDA product code for Bloom2 Programmable Electrophysiology Stimulator?

The FDA product code for Bloom2 Programmable Electrophysiology Stimulator is JOQ.

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