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FDA 510(k)

ELLIPSE 12PL, MODEL 9ESL7228

K-Number: K060516 · 2006-05-15

ApplicantDanish Dermatologic Development A/S
Decision Date2006-05-15
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ELLIPSE 12PL, MODEL 9ESL7228 is the device name listed in this FDA 510(k) record. The listed applicant is Danish Dermatologic Development A/S. It received FDA 510(k) clearance on 2006-05-15 under 510(k) number K060516. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELLIPSE 12PL, MODEL 9ESL7228?

ELLIPSE 12PL, MODEL 9ESL7228 is a medical device that received FDA 510(k) clearance on 2006-05-15. The listed applicant is Danish Dermatologic Development A/S. The 510(k) number is K060516.

When did ELLIPSE 12PL, MODEL 9ESL7228 receive FDA 510(k) clearance?

ELLIPSE 12PL, MODEL 9ESL7228 received FDA 510(k) clearance on 2006-05-15, under 510(k) number K060516.

Who is the listed applicant for ELLIPSE 12PL, MODEL 9ESL7228?

The FDA 510(k) record lists Danish Dermatologic Development A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELLIPSE 12PL, MODEL 9ESL7228?

The FDA product code for ELLIPSE 12PL, MODEL 9ESL7228 is GEX. This falls under the Gastroenterology category.

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Other records listing Danish Dermatologic Development A/S 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: GEX)

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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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