Transcend 365 miniCPAP System

FDA 510(k) K180388 · Somnetics International, Inc.

Substantially Equivalent

510(k) numberK180388

Submission

Device name
Transcend 365 miniCPAP System
Applicant
Somnetics International, Inc.
New Brighton, MN, US
Received
February 13, 2018
Decision date
November 30, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BZD – Ventilator, Non-Continuous (Respirator)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5905
Specialty
Anesthesiology

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Questions and answers

When was Transcend 365 miniCPAP System cleared by the FDA?

Transcend 365 miniCPAP System (K180388) received a 510(k) decision of Substantially Equivalent on November 30, 2018, 290 days after the submission was received.

What is the product code of K180388?

The FDA product code is BZD – Ventilator, Non-Continuous (Respirator), a Class II (moderate risk) device regulated under 21 CFR 868.5905.