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FDA 510(k)

HOLTER LX ANALYSIS

K-Number: K081861 · 2008-12-04

ApplicantNorth East Monitoring, Inc.
Decision Date2008-12-04
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HOLTER LX ANALYSIS is the device name listed in this FDA 510(k) record. The listed applicant is North East Monitoring, Inc.. It received FDA 510(k) clearance on 2008-12-04 under 510(k) number K081861. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOLTER LX ANALYSIS?

HOLTER LX ANALYSIS is a medical device that received FDA 510(k) clearance on 2008-12-04. The listed applicant is North East Monitoring, Inc.. The 510(k) number is K081861.

When did HOLTER LX ANALYSIS receive FDA 510(k) clearance?

HOLTER LX ANALYSIS received FDA 510(k) clearance on 2008-12-04, under 510(k) number K081861.

Who is the listed applicant for HOLTER LX ANALYSIS?

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

What is the FDA product code for HOLTER LX ANALYSIS?

The FDA product code for HOLTER LX ANALYSIS is MNR.

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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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