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FDA 510(k)

MODIFICATION TO: POCKETVIEW ECG SOFTWARE

K-Number: K013311 · 2002-01-03

ApplicantMicromedical Industries, Ltd.
Decision Date2002-01-03
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: POCKETVIEW ECG SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Micromedical Industries, Ltd.. It received FDA 510(k) clearance on 2002-01-03 under 510(k) number K013311. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO: POCKETVIEW ECG SOFTWARE?

MODIFICATION TO: POCKETVIEW ECG SOFTWARE is a medical device that received FDA 510(k) clearance on 2002-01-03. The listed applicant is Micromedical Industries, Ltd.. The 510(k) number is K013311.

When did MODIFICATION TO: POCKETVIEW ECG SOFTWARE receive FDA 510(k) clearance?

MODIFICATION TO: POCKETVIEW ECG SOFTWARE received FDA 510(k) clearance on 2002-01-03, under 510(k) number K013311.

Who is the listed applicant for MODIFICATION TO: POCKETVIEW ECG SOFTWARE?

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

What is the FDA product code for MODIFICATION TO: POCKETVIEW ECG SOFTWARE?

The FDA product code for MODIFICATION TO: POCKETVIEW ECG SOFTWARE is MHX.

Related Clinical Trials

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Other records listing Micromedical Industries, 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.

K012540BLY-501 ADAPTORK990266MICROMEDICAL 12 LEAD SIMULTANEOUS CABLEK922528CMS SYSTEMK915624MODIFIED BIOLOGK915627PACEVIEW

Related Devices (Code: MHX)

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.

K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0MGE Healthcare Finland OyK260343Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland OyK260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.K253277Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.K254209Radius VSM and AccessoriesMasimo Corporation

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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