Ombra Table Top Compressor
FDA 510(k) K131881 · Trudell Medical Intl.
510(k) numberK131881
Submission
- Device name
- Ombra Table Top Compressor
- Applicant
- Trudell Medical Intl.
London, CA - Received
- June 25, 2013
- Decision date
- October 24, 2013
- 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 Ombra Table Top Compressor cleared by the FDA?
Ombra Table Top Compressor (K131881) received a 510(k) decision of Substantially Equivalent on October 24, 2013, 121 days after the submission was received.
What is the product code of K131881?
The FDA product code is BTI – Compressor, Air, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.6250.