FDA 510(k)

Benesta Hysteroscope

N.º K: K192822 · 2020-09-09

Fecha de decisión2020-09-09

Código de productoHIH

Comité asesorOB

DecisiónSubstantially Equivalent

Resumen del dispositivo

Benesta Hysteroscope is the device name listed in this FDA 510(k) record. The listed applicant is Caldera Medical, Inc.. It received FDA 510(k) clearance on 2020-09-09 under 510(k) number K192822. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Benesta Hysteroscope?

Benesta Hysteroscope is a medical device that received FDA 510(k) clearance on 2020-09-09. The listed applicant is Caldera Medical, Inc.. The 510(k) number is K192822.

When did Benesta Hysteroscope receive FDA 510(k) clearance?

Benesta Hysteroscope received FDA 510(k) clearance on 2020-09-09, under 510(k) number K192822.

Who is the listed applicant for Benesta Hysteroscope?

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

What is the FDA product code for Benesta Hysteroscope?

The FDA product code for Benesta Hysteroscope is HIH.

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Otros registros que enlistan a Caldera Medical, Inc. como solicitante

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Fuente oficial

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