Transcend Heated Humidifier

FDA 510(k) K131388 · Somnetics International, Inc.

Substantially Equivalent

510(k) numberK131388

Submission

Device name
Transcend Heated Humidifier
Applicant
Somnetics International, Inc.
New Brighton, MN, US
Received
May 14, 2013
Decision date
September 26, 2013
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BTT – Humidifier, Respiratory Gas, (Direct Patient Interface)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5450
Specialty
Anesthesiology

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Questions and answers

When was Transcend Heated Humidifier cleared by the FDA?

Transcend Heated Humidifier (K131388) received a 510(k) decision of Substantially Equivalent on September 26, 2013, 135 days after the submission was received.

What is the product code of K131388?

The FDA product code is BTT – Humidifier, Respiratory Gas, (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5450.