Humidaire 2I
FDA 510(k) K080797 · Resmed, Ltd.
510(k) numberK080797
Submission
- Device name
- Humidaire 2I
- Applicant
- Resmed, Ltd.
Poway, CA, US - Received
- March 20, 2008
- Decision date
- July 9, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 Humidaire 2I cleared by the FDA?
Humidaire 2I (K080797) received a 510(k) decision of Substantially Equivalent on July 9, 2008, 111 days after the submission was received.
What is the product code of K080797?
The FDA product code is BTT – Humidifier, Respiratory Gas, (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5450.