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FDA 510(k)

DMS 300-7

K-Number: K062007 · 2006-08-16

ApplicantDiagnostic Monitoring Software
Decision Date2006-08-16
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DMS 300-7 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 2006-08-16 under 510(k) number K062007. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DMS 300-7?

DMS 300-7 is a medical device that received FDA 510(k) clearance on 2006-08-16. The listed applicant is Diagnostic Monitoring Software. The 510(k) number is K062007.

When did DMS 300-7 receive FDA 510(k) clearance?

DMS 300-7 received FDA 510(k) clearance on 2006-08-16, under 510(k) number K062007.

Who is the listed applicant for DMS 300-7?

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 DMS 300-7?

The FDA product code for DMS 300-7 is DSH.

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 300-4K062088PREMIER 11 HOLTERK911615HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 300

Related Devices (Code: DSH)

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.

K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.K253293VitaloJAK Clinic (Model 7100)Vitalograph , Ltd.K243650Zio® monitor (DFG0001)iRhythm Technologies, Inc.K243603AeviceMDAevice Health Pte. , Ltd.K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., 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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