FDA 510(k)

EM-TECH Passive Ultrasound Probe Strap

Número K: K254143 · 2026-08-10

Data da decisão2026-08-10

Código do produtoITX

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

EM-TECH Passive Ultrasound Probe Strap is the device name listed in this FDA 510(k) record. The listed applicant is EM-TECH Solutions, Inc.. It received FDA 510(k) clearance on 2026-08-10 under 510(k) number K254143. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

O que é o cinto de probe de ultrassom passivo EM-TECH?

EM-TECH Passive Ultrasound Probe Strap is a medical device that received FDA 510(k) clearance on 2026-08-10. The listed applicant is EM-TECH Solutions, Inc.. The 510(k) number is K254143.

When did EM-TECH Passive Ultrasound Probe Strap receive FDA 510(k) clearance?

EM-TECH Passive Ultrasound Probe Strap received FDA 510(k) clearance on 2026-08-10, under 510(k) number K254143.

Quem é o solicitante listado para o EM-TECH Passive Ultrasound Probe Strap?

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

What is the FDA product code for EM-TECH Passive Ultrasound Probe Strap?

The FDA product code for EM-TECH Passive Ultrasound Probe Strap is ITX.

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