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FDA 510(k)

TABLET COMMANDER

K-Number: K122285 · 2012-08-14

ApplicantCardiocom, LLC
Decision Date2012-08-14
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TABLET COMMANDER is the device name listed in this FDA 510(k) record. The listed applicant is Cardiocom, LLC. It received FDA 510(k) clearance on 2012-08-14 under 510(k) number K122285. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TABLET COMMANDER?

TABLET COMMANDER is a medical device that received FDA 510(k) clearance on 2012-08-14. The listed applicant is Cardiocom, LLC. The 510(k) number is K122285.

When did TABLET COMMANDER receive FDA 510(k) clearance?

TABLET COMMANDER received FDA 510(k) clearance on 2012-08-14, under 510(k) number K122285.

Who is the listed applicant for TABLET COMMANDER?

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 TABLET COMMANDER?

The FDA product code for TABLET COMMANDER is DRG.

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 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.

K091821COMMANDER 111, MODEL CD300-CD399K053303CARDIOCOM COMMANDER IIIK053304COMMANDER III NON-INVASIVE BLOOD PRESSURE SYSTEM

Related Devices (Code: DRG)

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.

K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.K252984Perin Health System (PHD80060-2)Perin Health Devices, LLCK252440EasyTeleMed (2.0.2)Ingeniars S.R.L.K250259TeleRehab Aermos Cardiopulmonary RehabilitationThe ScottCare CorporationK243837iBSMIorbit Digital Technologies Private LimitedK242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.

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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