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FDA 510(k)

PATIENT MONITOR

K-Number: K130056 · 2013-04-11

ApplicantLd Technology, LLC
Decision Date2013-04-11
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PATIENT MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Ld Technology, LLC. It received FDA 510(k) clearance on 2013-04-11 under 510(k) number K130056. 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 PATIENT MONITOR?

PATIENT MONITOR is a medical device that received FDA 510(k) clearance on 2013-04-11. The listed applicant is Ld Technology, LLC. The 510(k) number is K130056.

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

PATIENT MONITOR received FDA 510(k) clearance on 2013-04-11, under 510(k) number K130056.

Who is the listed applicant for PATIENT MONITOR?

The FDA 510(k) record lists Ld Technology, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PATIENT MONITOR?

The FDA product code for PATIENT MONITOR is MWI.

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Other records listing Ld Technology, LLC 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.

K200287BP-BT KioskK200141Oxi-W SystemK173696TBL-ABI SystemK160956LD-Oxi systemK131568SUDO PATHK113264ELECTRO SENSOR COMPLEX SOFTWARE (ES COMPLEX SOFTWARE)

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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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