Ventstar Heated, Infinity Id Breathing Circuit Heated
FDA 510(k) K102618 · Draeger Medical AG & Co. KG
510(k) numberK102618
Submission
- Device name
- Ventstar Heated, Infinity Id Breathing Circuit Heated
- Applicant
- Draeger Medical AG & Co. KG
Telford, PA, US - Received
- September 13, 2010
- Decision date
- December 10, 2010
- 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 Ventstar Heated, Infinity Id Breathing Circuit Heated cleared by the FDA?
Ventstar Heated, Infinity Id Breathing Circuit Heated (K102618) received a 510(k) decision of Substantially Equivalent on December 10, 2010, 88 days after the submission was received.
What is the product code of K102618?
The FDA product code is BTT – Humidifier, Respiratory Gas, (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5450.