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FDA 510(k)

PREMIER 11 HOLTER

K-Number: K062088 · 2006-08-25

ApplicantDiagnostic Monitoring Software
Decision Date2006-08-25
Product CodeMLO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PREMIER 11 HOLTER is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Monitoring Software. It received FDA 510(k) clearance on 2006-08-25 under 510(k) number K062088. 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 PREMIER 11 HOLTER?

PREMIER 11 HOLTER is a medical device that received FDA 510(k) clearance on 2006-08-25. The listed applicant is Diagnostic Monitoring Software. The 510(k) number is K062088.

When did PREMIER 11 HOLTER receive FDA 510(k) clearance?

PREMIER 11 HOLTER received FDA 510(k) clearance on 2006-08-25, under 510(k) number K062088.

Who is the listed applicant for PREMIER 11 HOLTER?

The FDA 510(k) record lists Diagnostic Monitoring Software as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PREMIER 11 HOLTER?

The FDA product code for PREMIER 11 HOLTER is MLO.

Related Clinical Trials

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.

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Other records listing Diagnostic Monitoring Software 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.

K062959DMS 300-2, 300-3 AND 300-4K062007DMS 300-7K911615HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 300

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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