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FDA 510(k)

COMMANDER 111, MODEL CD300-CD399

K-Number: K091821 · 2009-08-25

ApplicantCardiocom, LLC
Decision Date2009-08-25
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COMMANDER 111, MODEL CD300-CD399 is the device name listed in this FDA 510(k) record. The listed applicant is Cardiocom, LLC. It received FDA 510(k) clearance on 2009-08-25 under 510(k) number K091821. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMMANDER 111, MODEL CD300-CD399?

COMMANDER 111, MODEL CD300-CD399 is a medical device that received FDA 510(k) clearance on 2009-08-25. The listed applicant is Cardiocom, LLC. The 510(k) number is K091821.

When did COMMANDER 111, MODEL CD300-CD399 receive FDA 510(k) clearance?

COMMANDER 111, MODEL CD300-CD399 received FDA 510(k) clearance on 2009-08-25, under 510(k) number K091821.

Who is the listed applicant for COMMANDER 111, MODEL CD300-CD399?

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

What is the FDA product code for COMMANDER 111, MODEL CD300-CD399?

The FDA product code for COMMANDER 111, MODEL CD300-CD399 is DXN.

Related Clinical Trials

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Other records listing Cardiocom, LLC 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.

K122285TABLET COMMANDERK053303CARDIOCOM COMMANDER IIIK053304COMMANDER III NON-INVASIVE BLOOD PRESSURE SYSTEM

Related Devices (Code: DXN)

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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