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FDA 510(k)

ELLIPSE 4

K-Number: K964522 · 1997-03-21

ApplicantAndromeda Medizinische Systeme GmbH
Decision Date1997-03-21
Product CodeFEN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ELLIPSE 4 is the device name listed in this FDA 510(k) record. The listed applicant is Andromeda Medizinische Systeme GmbH. It received FDA 510(k) clearance on 1997-03-21 under 510(k) number K964522. The device is classified under product code FEN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELLIPSE 4?

ELLIPSE 4 is a medical device that received FDA 510(k) clearance on 1997-03-21. The listed applicant is Andromeda Medizinische Systeme GmbH. The 510(k) number is K964522.

When did ELLIPSE 4 receive FDA 510(k) clearance?

ELLIPSE 4 received FDA 510(k) clearance on 1997-03-21, under 510(k) number K964522.

Who is the listed applicant for ELLIPSE 4?

The FDA 510(k) record lists Andromeda Medizinische Systeme GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELLIPSE 4?

The FDA product code for ELLIPSE 4 is FEN.

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Related Devices (Code: FEN)

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

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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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