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FDA 510(k)

Jensen Shade Effect Liquids

K-Number: K183408 · 2019-03-20

ApplicantJensen Industries, Inc.
Decision Date2019-03-20
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Jensen Shade Effect Liquids is the device name listed in this FDA 510(k) record. The listed applicant is Jensen Industries, Inc.. It received FDA 510(k) clearance on 2019-03-20 under 510(k) number K183408. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Jensen Shade Effect Liquids?

Jensen Shade Effect Liquids is a medical device that received FDA 510(k) clearance on 2019-03-20. The listed applicant is Jensen Industries, Inc.. The 510(k) number is K183408.

When did Jensen Shade Effect Liquids receive FDA 510(k) clearance?

Jensen Shade Effect Liquids received FDA 510(k) clearance on 2019-03-20, under 510(k) number K183408.

Who is the listed applicant for Jensen Shade Effect Liquids?

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

What is the FDA product code for Jensen Shade Effect Liquids?

The FDA product code for Jensen Shade Effect Liquids is EIH.

Related Devices (Code: EIH)

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

View on FDA Database →

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

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