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FDA 510(k)

OMEGA 21 SYSTEM

K-Number: K973683 · 1997-12-24

ApplicantEbi Electro Biology
Decision Date1997-12-24
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

OMEGA 21 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ebi Electro Biology. It received FDA 510(k) clearance on 1997-12-24 under 510(k) number K973683. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the OMEGA 21 SYSTEM?

OMEGA 21 SYSTEM is a medical device that received FDA 510(k) clearance on 1997-12-24. The listed applicant is Ebi Electro Biology. The 510(k) number is K973683.

When did OMEGA 21 SYSTEM receive FDA 510(k) clearance?

OMEGA 21 SYSTEM received FDA 510(k) clearance on 1997-12-24, under 510(k) number K973683.

Who is the listed applicant for OMEGA 21 SYSTEM?

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

What is the FDA product code for OMEGA 21 SYSTEM?

The FDA product code for OMEGA 21 SYSTEM is MNH. This falls under the ENT category.

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 Ebi Electro Biology 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.

K991721EBI OMEGA 21 SYSTEMK973923EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM

Related Devices (Code: MNH)

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.

K162066Reliance Spinal Screw SystemReliance Medical Systems, LLCK162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd.K162143FixxSure® X-LinkInnovasis, Inc.K161151Spinal fixation systemCanwell Medical Co., Ltd.K162189ANAX™ 5.5 Spinal SystemU&I CorporationK151362HC Spinal SystemHung Chun Bio-S 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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