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FDA 510(k)

TRIMIRA OCS 3000

K-Number: K082603 · 2008-12-12

ApplicantRemicalm, LLC
Decision Date2008-12-12
Product CodeNXV
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TRIMIRA OCS 3000 is the device name listed in this FDA 510(k) record. The listed applicant is Remicalm, LLC. It received FDA 510(k) clearance on 2008-12-12 under 510(k) number K082603. The device is classified under product code NXV. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIMIRA OCS 3000?

TRIMIRA OCS 3000 is a medical device that received FDA 510(k) clearance on 2008-12-12. The listed applicant is Remicalm, LLC. The 510(k) number is K082603.

When did TRIMIRA OCS 3000 receive FDA 510(k) clearance?

TRIMIRA OCS 3000 received FDA 510(k) clearance on 2008-12-12, under 510(k) number K082603.

Who is the listed applicant for TRIMIRA OCS 3000?

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

What is the FDA product code for TRIMIRA OCS 3000?

The FDA product code for TRIMIRA OCS 3000 is NXV.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Remicalm, 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.

K090135TRIMIRA IDENTAFI 3000

Related Devices (Code: NXV)

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.

K123169ORALIDForward Science, LLCK121282MICROLUX/DL MICROLUX/BLU BIO/SCREENAddent, Inc.K102083VELSCOPE VXLed Dental, Inc.K101140DENTLIGHT ORAL EXAM LIGHT KITDentlight, Inc.K090135TRIMIRA IDENTAFI 3000Remicalm, LLCK082668BIO-SCREENAddent, Inc.

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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