FDA 510(k)

JEJE TEETHER

K-Number: K034017 · 2004-10-18

ApplicantVibe 2000

Decision Date2004-10-18

Product CodeMEF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

JEJE TEETHER is the device name listed in this FDA 510(k) record. The listed applicant is Vibe 2000. It received FDA 510(k) clearance on 2004-10-18 under 510(k) number K034017. The device is classified under product code MEF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JEJE TEETHER?

JEJE TEETHER is a medical device that received FDA 510(k) clearance on 2004-10-18. The listed applicant is Vibe 2000. The 510(k) number is K034017.

When did JEJE TEETHER receive FDA 510(k) clearance?

JEJE TEETHER received FDA 510(k) clearance on 2004-10-18, under 510(k) number K034017.

Who is the listed applicant for JEJE TEETHER?

The FDA 510(k) record lists Vibe 2000 as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JEJE TEETHER?

The FDA product code for JEJE TEETHER is MEF.

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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.