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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 the device name listed in this FDA 510(k) record. The listed applicant is Somnetics International, Inc.. It received FDA 510(k) clearance on 2018-11-30 under 510(k) 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. The listed applicant is Somnetics International, Inc.. The 510(k) number is K180388.

When did Transcend 365 miniCPAP System receive FDA 510(k) clearance?

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

Who is the listed applicant for Transcend 365 miniCPAP System?

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

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

The FDA product code for Transcend 365 miniCPAP System is BZD.

Related Devices (Code: BZD)

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.

K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.K253553OrionResmed CorpK254104ResScan EssentialsResmed CorpK251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face MaskDcstar, Inc.K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.K252338MySleepDashSomnetics International, Inc. (Dba Transcend Inc)

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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