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FDA 510(k)

DM-400 HOLTER ECG CASSETTE RECORDER

K-Number: K970298 · 1997-08-20

ApplicantDiagnostic Monitoring
Decision Date1997-08-20
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DM-400 HOLTER ECG CASSETTE RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Monitoring. It received FDA 510(k) clearance on 1997-08-20 under 510(k) number K970298. 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 DM-400 HOLTER ECG CASSETTE RECORDER?

DM-400 HOLTER ECG CASSETTE RECORDER is a medical device that received FDA 510(k) clearance on 1997-08-20. The listed applicant is Diagnostic Monitoring. The 510(k) number is K970298.

When did DM-400 HOLTER ECG CASSETTE RECORDER receive FDA 510(k) clearance?

DM-400 HOLTER ECG CASSETTE RECORDER received FDA 510(k) clearance on 1997-08-20, under 510(k) number K970298.

Who is the listed applicant for DM-400 HOLTER ECG CASSETTE RECORDER?

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

What is the FDA product code for DM-400 HOLTER ECG CASSETTE RECORDER?

The FDA product code for DM-400 HOLTER ECG CASSETTE RECORDER is DSH.

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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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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