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FDA 510(k)

VISI MOBILE MONITIORING SYSTEM

K-Number: K133586 · 2013-12-18

ApplicantSotera Wireless, Inc.
Decision Date2013-12-18
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VISI MOBILE MONITIORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sotera Wireless, Inc.. It received FDA 510(k) clearance on 2013-12-18 under 510(k) number K133586. 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 VISI MOBILE MONITIORING SYSTEM?

VISI MOBILE MONITIORING SYSTEM is a medical device that received FDA 510(k) clearance on 2013-12-18. The listed applicant is Sotera Wireless, Inc.. The 510(k) number is K133586.

When did VISI MOBILE MONITIORING SYSTEM receive FDA 510(k) clearance?

VISI MOBILE MONITIORING SYSTEM received FDA 510(k) clearance on 2013-12-18, under 510(k) number K133586.

Who is the listed applicant for VISI MOBILE MONITIORING SYSTEM?

The FDA 510(k) record lists Sotera Wireless, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VISI MOBILE MONITIORING SYSTEM?

The FDA product code for VISI MOBILE MONITIORING 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 Sotera Wireless, Inc. 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.

K180472ViSi Mobile Monitoring SystemK130709VISI MOBILE MONITORING SYSTEMK122036VISI MOBILE MONITORING SYSTEMK112478VISI MOBILE MONITORING SYSTEM

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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