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FDA 510(k)

PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500

K-Number: K113183 · 2012-02-09

ApplicantShanghai 3f Electronics Co, Ltd.
Decision Date2012-02-09
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500 is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai 3f Electronics Co, Ltd.. It received FDA 510(k) clearance on 2012-02-09 under 510(k) number K113183. 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 PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500?

PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500 is a medical device that received FDA 510(k) clearance on 2012-02-09. The listed applicant is Shanghai 3f Electronics Co, Ltd.. The 510(k) number is K113183.

When did PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500 receive FDA 510(k) clearance?

PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500 received FDA 510(k) clearance on 2012-02-09, under 510(k) number K113183.

Who is the listed applicant for PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500?

The FDA 510(k) record lists Shanghai 3f Electronics Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500?

The FDA product code for PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500 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 Shanghai 3f Electronics Co, Ltd. 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.

K100394MULTI-PARAMETER PATIENT MONITOR, MODEL# PMS8210A

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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