FDA 510(k)

CHLOE BLAST

Número K: K243851 · 2025-08-15

Data da decisão2025-08-15

Código do produtoPBH

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

CHLOE BLAST is the device name listed in this FDA 510(k) record. The listed applicant is Fairtility , Ltd.. It received FDA 510(k) clearance on 2025-08-15 under 510(k) number K243851. The device is classified under product code PBH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CHLOE BLAST?

CHLOE BLAST is a medical device that received FDA 510(k) clearance on 2025-08-15. The listed applicant is Fairtility , Ltd.. The 510(k) number is K243851.

When did CHLOE BLAST receive FDA 510(k) clearance?

CHLOE BLAST received FDA 510(k) clearance on 2025-08-15, under 510(k) number K243851.

Who is the listed applicant for CHLOE BLAST?

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

What is the FDA product code for CHLOE BLAST?

The FDA product code for CHLOE BLAST is PBH.

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