FDA 510(k)

Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)

Número K: K253196 · 2026-06-12

Data da decisão2026-06-12

Código do produtoMWI

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) is the device name listed in this FDA 510(k) record. The listed applicant is Midmark Corporation. It received FDA 510(k) clearance on 2026-06-12 under 510(k) number K253196. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)?

Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) is a medical device that received FDA 510(k) clearance on 2026-06-12. The listed applicant is Midmark Corporation. The 510(k) number is K253196.

When did Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) receive FDA 510(k) clearance?

Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) received FDA 510(k) clearance on 2026-06-12, under 510(k) number K253196.

Who is the listed applicant for Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)?

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

What is the FDA product code for Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)?

The FDA product code for Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) is MWI.

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Outros registros que listam Midmark Corporation como candidato(a)

K251626Midmark Dental Delivery System K233026Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer K201667Midmark Extraoral Imaging System (EOIS)K163337Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer K161909IQvitals Zone

Dispositivos Relacionados (Código: MWI)

K260438Vital Signs Monitor (CLEO2)Infinium Medical, Inc.K253417Masimo Root Monitoring SystemMasimo Corporation K253436c-med0 alphaCosinuss GmbH K250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel Medical K241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.

Fonte oficial

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