Ventilair II Medical Air Compressor
FDA 510(k) K041781 · Hamilton Medical AG
510(k) numberK041781
Submission
- Device name
- Ventilair II Medical Air Compressor
- Applicant
- Hamilton Medical AG
Reno, NV, US - Received
- July 1, 2004
- Decision date
- March 14, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BTI – Compressor, Air, Portable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.6250
- Specialty
- Anesthesiology
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Questions and answers
When was Ventilair II Medical Air Compressor cleared by the FDA?
Ventilair II Medical Air Compressor (K041781) received a 510(k) decision of Substantially Equivalent on March 14, 2005, 256 days after the submission was received.
What is the product code of K041781?
The FDA product code is BTI – Compressor, Air, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.6250.