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FDA 510(k)

Transcend 365 miniCPAP System

K-Number: K180388 · 2018-11-30

ApplicantSomnetics International, Inc.
Decision Date2018-11-30
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Transcend 365 miniCPAP System is a medical device manufactured by Somnetics International, Inc.. It received FDA 510(k) clearance on 2018-11-30 under approval number K180388. 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 Transcend 365 miniCPAP System?

Transcend 365 miniCPAP System is a medical device that received FDA 510(k) clearance on 2018-11-30. It is manufactured by Somnetics International, Inc.. The 510(k) number is K180388.

When was Transcend 365 miniCPAP System approved by the FDA?

Transcend 365 miniCPAP System received FDA 510(k) clearance on 2018-11-30, under approval number K180388.

What company makes Transcend 365 miniCPAP System?

Transcend 365 miniCPAP System is manufactured by Somnetics International, Inc..

What is the FDA product code for Transcend 365 miniCPAP System?

The FDA product code for Transcend 365 miniCPAP System 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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