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FDA 510(k)

PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS)

K-Number: K110463 · 2011-11-10

ApplicantNorav Medical , Ltd.
Decision Date2011-11-10
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS) is the device name listed in this FDA 510(k) record. The listed applicant is Norav Medical , Ltd.. It received FDA 510(k) clearance on 2011-11-10 under 510(k) number K110463. 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 PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS)?

PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS) is a medical device that received FDA 510(k) clearance on 2011-11-10. The listed applicant is Norav Medical , Ltd.. The 510(k) number is K110463.

When did PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS) receive FDA 510(k) clearance?

PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS) received FDA 510(k) clearance on 2011-11-10, under 510(k) number K110463.

Who is the listed applicant for PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS)?

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

What is the FDA product code for PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS)?

The FDA product code for PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS) is MWI.

Related Clinical Trials

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Other records listing Norav Medical , 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.

K080141PC ECG 1200W SYSTEMK012712NORAV HOLTER SYSTEM, MODEL NH-300 V1.07K000404PC ECG 1200

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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