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FDA 510(k)

ELFCARE DEVICE, MODELS 314A THROUGH 314G

K-Number: K023231 · 2003-04-04

ApplicantMediseb , Ltd.
Decision Date2003-04-04
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ELFCARE DEVICE, MODELS 314A THROUGH 314G is the device name listed in this FDA 510(k) record. The listed applicant is Mediseb , Ltd.. It received FDA 510(k) clearance on 2003-04-04 under 510(k) number K023231. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELFCARE DEVICE, MODELS 314A THROUGH 314G?

ELFCARE DEVICE, MODELS 314A THROUGH 314G is a medical device that received FDA 510(k) clearance on 2003-04-04. The listed applicant is Mediseb , Ltd.. The 510(k) number is K023231.

When did ELFCARE DEVICE, MODELS 314A THROUGH 314G receive FDA 510(k) clearance?

ELFCARE DEVICE, MODELS 314A THROUGH 314G received FDA 510(k) clearance on 2003-04-04, under 510(k) number K023231.

Who is the listed applicant for ELFCARE DEVICE, MODELS 314A THROUGH 314G?

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

What is the FDA product code for ELFCARE DEVICE, MODELS 314A THROUGH 314G?

The FDA product code for ELFCARE DEVICE, MODELS 314A THROUGH 314G is GZJ.

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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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