FDA 510(k)

SAPPHIRE, ELEVARE SAPPHIRE

K-Number: K172555 · 2018-05-01

ApplicantOmm Imports, Inc. D/B/A Zero Gravity

Decision Date2018-05-01

Product CodeOLP

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

SAPPHIRE, ELEVARE SAPPHIRE is a medical device manufactured by Omm Imports, Inc. D/B/A Zero Gravity. It received FDA 510(k) clearance on 2018-05-01 under approval number K172555. The device is classified under product code OLP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAPPHIRE, ELEVARE SAPPHIRE?

SAPPHIRE, ELEVARE SAPPHIRE is a medical device that received FDA 510(k) clearance on 2018-05-01. It is manufactured by Omm Imports, Inc. D/B/A Zero Gravity. The 510(k) number is K172555.

When was SAPPHIRE, ELEVARE SAPPHIRE approved by the FDA?

SAPPHIRE, ELEVARE SAPPHIRE received FDA 510(k) clearance on 2018-05-01, under approval number K172555.

What company makes SAPPHIRE, ELEVARE SAPPHIRE?

SAPPHIRE, ELEVARE SAPPHIRE is manufactured by Omm Imports, Inc. D/B/A Zero Gravity.

What is the FDA product code for SAPPHIRE, ELEVARE SAPPHIRE?

The FDA product code for SAPPHIRE, ELEVARE SAPPHIRE is OLP.

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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.