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FDA 510(k)

EXELO2, MODEL 4010

K-Number: K090639 · 2009-10-29

ApplicantQuantel Derma GmbH
Decision Date2009-10-29
Product CodeONG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EXELO2, MODEL 4010 is the device name listed in this FDA 510(k) record. The listed applicant is Quantel Derma GmbH. It received FDA 510(k) clearance on 2009-10-29 under 510(k) number K090639. The device is classified under product code ONG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXELO2, MODEL 4010?

EXELO2, MODEL 4010 is a medical device that received FDA 510(k) clearance on 2009-10-29. The listed applicant is Quantel Derma GmbH. The 510(k) number is K090639.

When did EXELO2, MODEL 4010 receive FDA 510(k) clearance?

EXELO2, MODEL 4010 received FDA 510(k) clearance on 2009-10-29, under 510(k) number K090639.

Who is the listed applicant for EXELO2, MODEL 4010?

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

What is the FDA product code for EXELO2, MODEL 4010?

The FDA product code for EXELO2, MODEL 4010 is ONG.

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Other records listing Quantel Derma GmbH 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.

K090762LEDA

Related Devices (Code: ONG)

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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