FDA 510(k)

SoftSpot

Número K: K212045 · 2021-09-28

Data da decisão2021-09-28

Código do produtoQQO

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

SoftSpot is the device name listed in this FDA 510(k) record. The listed applicant is Pediametrix, Inc.. It received FDA 510(k) clearance on 2021-09-28 under 510(k) number K212045. The device is classified under product code QQO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SoftSpot?

SoftSpot is a medical device that received FDA 510(k) clearance on 2021-09-28. The listed applicant is Pediametrix, Inc.. The 510(k) number is K212045.

When did SoftSpot receive FDA 510(k) clearance?

SoftSpot received FDA 510(k) clearance on 2021-09-28, under 510(k) number K212045.

Who is the listed applicant for SoftSpot?

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

What is the FDA product code for SoftSpot?

The FDA product code for SoftSpot is QQO.

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