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FDA 510(k)

SMDIE DEVICE INTERFACING SYSTEM

K-Number: K061590 · 2006-06-21

ApplicantSiemens Medical Solutions Health Services Corporat
Decision Date2006-06-21
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SMDIE DEVICE INTERFACING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions Health Services Corporat. It received FDA 510(k) clearance on 2006-06-21 under 510(k) number K061590. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMDIE DEVICE INTERFACING SYSTEM?

SMDIE DEVICE INTERFACING SYSTEM is a medical device that received FDA 510(k) clearance on 2006-06-21. The listed applicant is Siemens Medical Solutions Health Services Corporat. The 510(k) number is K061590.

When did SMDIE DEVICE INTERFACING SYSTEM receive FDA 510(k) clearance?

SMDIE DEVICE INTERFACING SYSTEM received FDA 510(k) clearance on 2006-06-21, under 510(k) number K061590.

Who is the listed applicant for SMDIE DEVICE INTERFACING SYSTEM?

The FDA 510(k) record lists Siemens Medical Solutions Health Services Corporat as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMDIE DEVICE INTERFACING SYSTEM?

The FDA product code for SMDIE DEVICE INTERFACING SYSTEM is MWI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Siemens Medical Solutions Health Services Corporat as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K946117MEDICAL IMAGE MANAGEMENT SYSTEM (MIM)K933098MEDICAL IMAGE MANAGEMENT SYSTEM/X-RAY TERMINAL

Related Devices (Code: MWI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260438Vital Signs Monitor (CLEO2)Infinium Medical, Inc.K253417Masimo Root Monitoring SystemMasimo CorporationK253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark CorporationK253436c-med0 alphaCosinuss GmbHK250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel MedicalK241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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