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FDA 510(k)

Sapphire

K-Number: K152356 · 2016-01-08

ApplicantRespironics, Inc.
Decision Date2016-01-08
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Sapphire is a medical device manufactured by Respironics, Inc.. It received FDA 510(k) clearance on 2016-01-08 under approval number K152356. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sapphire?

Sapphire is a medical device that received FDA 510(k) clearance on 2016-01-08. It is manufactured by Respironics, Inc.. The 510(k) number is K152356.

When was Sapphire approved by the FDA?

Sapphire received FDA 510(k) clearance on 2016-01-08, under approval number K152356.

What company makes Sapphire?

Sapphire is manufactured by Respironics, Inc..

What is the FDA product code for Sapphire?

The FDA product code for Sapphire is BZD.

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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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