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FDA 510(k)

3400E series; E5400 series; E6400 series; Sundazzler series

K-Number: K151905 · 2016-03-01

ApplicantHeartland Tanning, Inc.
Decision Date2016-03-01
Product CodeLEJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

3400E series; E5400 series; E6400 series; Sundazzler series is the device name listed in this FDA 510(k) record. The listed applicant is Heartland Tanning, Inc.. It received FDA 510(k) clearance on 2016-03-01 under 510(k) number K151905. The device is classified under product code LEJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3400E series; E5400 series; E6400 series; Sundazzler series?

3400E series; E5400 series; E6400 series; Sundazzler series is a medical device that received FDA 510(k) clearance on 2016-03-01. The listed applicant is Heartland Tanning, Inc.. The 510(k) number is K151905.

When did 3400E series; E5400 series; E6400 series; Sundazzler series receive FDA 510(k) clearance?

3400E series; E5400 series; E6400 series; Sundazzler series received FDA 510(k) clearance on 2016-03-01, under 510(k) number K151905.

Who is the listed applicant for 3400E series; E5400 series; E6400 series; Sundazzler series?

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

What is the FDA product code for 3400E series; E5400 series; E6400 series; Sundazzler series?

The FDA product code for 3400E series; E5400 series; E6400 series; Sundazzler series is LEJ.

Related Devices (Code: LEJ)

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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