FDA 510(k)

Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)

N.º K: K191264 · 2019-10-30

Fecha de decisión2019-10-30

Código de productoOQY

Comité asesorOB

DecisiónSubstantially Equivalent

Resumen del dispositivo

Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”) is the device name listed in this FDA 510(k) record. The listed applicant is Ujenzi Charitable Trust. It received FDA 510(k) clearance on 2019-10-30 under 510(k) number K191264. The device is classified under product code OQY. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)?

Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”) is a medical device that received FDA 510(k) clearance on 2019-10-30. The listed applicant is Ujenzi Charitable Trust. The 510(k) number is K191264.

When did Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”) receive FDA 510(k) clearance?

Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”) received FDA 510(k) clearance on 2019-10-30, under 510(k) number K191264.

Who is the listed applicant for Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)?

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

What is the FDA product code for Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)?

The FDA product code for Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”) is OQY.

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