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FDA 510(k)

MODIFICATION TO ZYMED HOLTER 2000

K-Number: K992197 · 1999-07-28

ApplicantZymed Medical Instrumentation
Decision Date1999-07-28
Product CodeMLO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO ZYMED HOLTER 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Zymed Medical Instrumentation. It received FDA 510(k) clearance on 1999-07-28 under 510(k) number K992197. The device is classified under product code MLO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO ZYMED HOLTER 2000?

MODIFICATION TO ZYMED HOLTER 2000 is a medical device that received FDA 510(k) clearance on 1999-07-28. The listed applicant is Zymed Medical Instrumentation. The 510(k) number is K992197.

When did MODIFICATION TO ZYMED HOLTER 2000 receive FDA 510(k) clearance?

MODIFICATION TO ZYMED HOLTER 2000 received FDA 510(k) clearance on 1999-07-28, under 510(k) number K992197.

Who is the listed applicant for MODIFICATION TO ZYMED HOLTER 2000?

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

What is the FDA product code for MODIFICATION TO ZYMED HOLTER 2000?

The FDA product code for MODIFICATION TO ZYMED HOLTER 2000 is MLO.

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Other records listing Zymed Medical Instrumentation 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.

K002004ZYBITK990170HOLTER 2000K984089ZYMED TELEMETRY SYSTEM, MODEL EASI VIEWK955015ZYMED HOLTER SCANNER MODEL 2010K951370ZYMED TELEMETRY SYSTEM; MODEL T8010K930894MULTITRAK-PLUS

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Related Devices (Code: MLO)

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.

K261580ZBPro Diagnostic (Version 2.0)Zbeats, Inc.K241890Philips Holter Analysis SystemPhilips Medizin Systeme Böblingen GmbHK240794Frontier X PlusFourth Frontier Technologies Pvt, Ltd.K200833RX-1 Rhythm Express Remote Cardiac Monitoring SystemVivaQuant, Inc.K193177CER-SCardiocalmK182030Faros MobileBittium Biosignals , Ltd.

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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