RTC 26-C Inline Aerosol Adapter
FDA 510(k) K162753 · Instrumentation Industries, Inc.
510(k) numberK162753
Submission
- Device name
- RTC 26-C Inline Aerosol Adapter
- Applicant
- Instrumentation Industries, Inc.
Bethel Park, PA, US - Received
- September 30, 2016
- Decision date
- February 28, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAF – Nebulizer (Direct Patient Interface)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5630
- Specialty
- Anesthesiology
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Questions and answers
When was RTC 26-C Inline Aerosol Adapter cleared by the FDA?
RTC 26-C Inline Aerosol Adapter (K162753) received a 510(k) decision of Substantially Equivalent on February 28, 2017, 151 days after the submission was received.
What is the product code of K162753?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.