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FDA 510(k)

TEMPUSIC PATIENT MONITOR

K-Number: K113105 · 2011-12-15

ApplicantRemote Diagnostic Technologies , Ltd.
Decision Date2011-12-15
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TEMPUSIC PATIENT MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Remote Diagnostic Technologies , Ltd.. It received FDA 510(k) clearance on 2011-12-15 under 510(k) number K113105. 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 TEMPUSIC PATIENT MONITOR?

TEMPUSIC PATIENT MONITOR is a medical device that received FDA 510(k) clearance on 2011-12-15. The listed applicant is Remote Diagnostic Technologies , Ltd.. The 510(k) number is K113105.

When did TEMPUSIC PATIENT MONITOR receive FDA 510(k) clearance?

TEMPUSIC PATIENT MONITOR received FDA 510(k) clearance on 2011-12-15, under 510(k) number K113105.

Who is the listed applicant for TEMPUSIC PATIENT MONITOR?

The FDA 510(k) record lists Remote Diagnostic Technologies , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TEMPUSIC PATIENT MONITOR?

The FDA product code for TEMPUSIC PATIENT MONITOR is MWI.

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Other records listing Remote Diagnostic Technologies , 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.

K173768Tempus Pro Patient MonitorK170567Tempus Pro Patient MonitorK130773TEMPUS PRO PATIENT MONITORK101264TEMPUS IC PROFESSIONAL PATIENT MONITORK082718TEMPUSIC PATIENT MONITORK033410TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002

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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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