FDA 510(k)

SmartSpectra Vital Signs Monitor 1.0

Número K: K254169 · 2026-06-18

RequerentePresage Security, Inc. d/b/a Presage Technologies, Inc.

Data da decisão2026-06-18

Código do produtoQME

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

SmartSpectra Vital Signs Monitor 1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Presage Security, Inc. d/b/a Presage Technologies, Inc.. It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K254169. The device is classified under product code QME. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SmartSpectra Vital Signs Monitor 1.0?

SmartSpectra Vital Signs Monitor 1.0 is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is Presage Security, Inc. d/b/a Presage Technologies, Inc.. The 510(k) number is K254169.

When did SmartSpectra Vital Signs Monitor 1.0 receive FDA 510(k) clearance?

SmartSpectra Vital Signs Monitor 1.0 received FDA 510(k) clearance on 2026-06-18, under 510(k) number K254169.

Who is the listed applicant for SmartSpectra Vital Signs Monitor 1.0?

The FDA 510(k) record lists Presage Security, Inc. d/b/a Presage Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SmartSpectra Vital Signs Monitor 1.0?

The FDA product code for SmartSpectra Vital Signs Monitor 1.0 is QME.

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