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FDA 510(k)

DEBP

K-Number: K092783 · 2009-10-22

ApplicantEnko , Ltd.
Decision Date2009-10-22
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

DEBP is the device name listed in this FDA 510(k) record. The listed applicant is Enko , Ltd.. It received FDA 510(k) clearance on 2009-10-22 under 510(k) number K092783. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEBP?

DEBP is a medical device that received FDA 510(k) clearance on 2009-10-22. The listed applicant is Enko , Ltd.. The 510(k) number is K092783.

When did DEBP receive FDA 510(k) clearance?

DEBP received FDA 510(k) clearance on 2009-10-22, under 510(k) number K092783.

Who is the listed applicant for DEBP?

The FDA 510(k) record lists Enko , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEBP?

The FDA product code for DEBP is HGX.

Related Devices (Code: HGX)

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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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