Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)
FDA 510(k) K223100 · Medline Industries, Inc.
510(k) numberK223100
Submission
- Device name
- Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)
- Applicant
- Medline Industries, Inc.
Northfiled, IL, US - Received
- September 30, 2022
- Decision date
- June 27, 2023
- 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 Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14) cleared by the FDA?
Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14) (K223100) received a 510(k) decision of Substantially Equivalent on June 27, 2023, 270 days after the submission was received.
What is the product code of K223100?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.