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FDA 510(k)

MULTI-PARAMETER PATIENT MONITOR, MODEL# PMS8210A

K-Number: K100394 · 2010-04-15

ApplicantShanghai 3f Electronics Co, Ltd.
Decision Date2010-04-15
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MULTI-PARAMETER PATIENT MONITOR, MODEL# PMS8210A 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 2010-04-15 under 510(k) number K100394. 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 MULTI-PARAMETER PATIENT MONITOR, MODEL# PMS8210A?

MULTI-PARAMETER PATIENT MONITOR, MODEL# PMS8210A is a medical device that received FDA 510(k) clearance on 2010-04-15. The listed applicant is Shanghai 3f Electronics Co, Ltd.. The 510(k) number is K100394.

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

MULTI-PARAMETER PATIENT MONITOR, MODEL# PMS8210A received FDA 510(k) clearance on 2010-04-15, under 510(k) number K100394.

Who is the listed applicant for MULTI-PARAMETER PATIENT MONITOR, MODEL# PMS8210A?

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 MULTI-PARAMETER PATIENT MONITOR, MODEL# PMS8210A?

The FDA product code for MULTI-PARAMETER PATIENT MONITOR, MODEL# PMS8210A 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.

K113183PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500

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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