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FDA 510(k)

EBI OMEGA 21 SYSTEM

K-Number: K992333 · 1999-10-08

ApplicantElectro-Biology, Inc.
Decision Date1999-10-08
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EBI OMEGA 21 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Electro-Biology, Inc.. It received FDA 510(k) clearance on 1999-10-08 under 510(k) number K992333. The device is classified under product code MNI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EBI OMEGA 21 SYSTEM?

EBI OMEGA 21 SYSTEM is a medical device that received FDA 510(k) clearance on 1999-10-08. The listed applicant is Electro-Biology, Inc.. The 510(k) number is K992333.

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

EBI OMEGA 21 SYSTEM received FDA 510(k) clearance on 1999-10-08, under 510(k) number K992333.

Who is the listed applicant for EBI OMEGA 21 SYSTEM?

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

What is the FDA product code for EBI OMEGA 21 SYSTEM?

The FDA product code for EBI OMEGA 21 SYSTEM is MNI.

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Other records listing Electro-Biology, Inc. 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.

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Related Devices (Code: MNI)

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

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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