Breas, Model HA01

FDA 510(k) K060790 · Breas Medical AB

Substantially Equivalent

510(k) numberK060790

Submission

Device name
Breas, Model HA01
Applicant
Breas Medical AB
Molnlycke, SE
Received
March 23, 2006
Decision date
May 25, 2006
Decision
Substantially Equivalent (SESE)
Type
Special 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 Breas, Model HA01 cleared by the FDA?

Breas, Model HA01 (K060790) received a 510(k) decision of Substantially Equivalent on May 25, 2006, 63 days after the submission was received.

What is the product code of K060790?

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