Gas Transfill
FDA 510(k) K091191 · Respironics Inc., Sleep & Home Respiratory Group
510(k) numberK091191
Submission
- Device name
- Gas Transfill
- Applicant
- Respironics Inc., Sleep & Home Respiratory Group
Murrysville, PA, US - Received
- April 23, 2009
- Decision date
- October 23, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAW – Generator, Oxygen, Portable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5440
- Specialty
- Anesthesiology
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Questions and answers
When was Gas Transfill cleared by the FDA?
Gas Transfill (K091191) received a 510(k) decision of Substantially Equivalent on October 23, 2009, 183 days after the submission was received.
What is the product code of K091191?
The FDA product code is CAW – Generator, Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5440.