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FDA 510(k)

ELLIPSE 2.3

K-Number: K905621 · 1990-12-21

ApplicantEverest & Jennings, Inc.
Decision Date1990-12-21
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ELLIPSE 2.3 is the device name listed in this FDA 510(k) record. The listed applicant is Everest & Jennings, Inc.. It received FDA 510(k) clearance on 1990-12-21 under 510(k) number K905621. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELLIPSE 2.3?

ELLIPSE 2.3 is a medical device that received FDA 510(k) clearance on 1990-12-21. The listed applicant is Everest & Jennings, Inc.. The 510(k) number is K905621.

When did ELLIPSE 2.3 receive FDA 510(k) clearance?

ELLIPSE 2.3 received FDA 510(k) clearance on 1990-12-21, under 510(k) number K905621.

Who is the listed applicant for ELLIPSE 2.3?

The FDA 510(k) record lists Everest & Jennings, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELLIPSE 2.3?

The FDA product code for ELLIPSE 2.3 is IOR.

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Other records listing Everest & Jennings, 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: IOR)

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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