Hudson Rci Aquapak Humidifier Adaptor
FDA 510(k) K141353 · Teleflexmedical, Inc.
510(k) numberK141353
Submission
- Device name
- Hudson Rci Aquapak Humidifier Adaptor
- Applicant
- Teleflexmedical, Inc.
Research Triangle Park, NC, US - Received
- May 23, 2014
- Decision date
- August 1, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BTT – Humidifier, Respiratory Gas, (Direct Patient Interface)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5450
- Specialty
- Anesthesiology
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| K240163 | Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus CannulaBTT · Traditional | Medline Industries, LP | 09/27/2024SE |
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Questions and answers
When was Hudson Rci Aquapak Humidifier Adaptor cleared by the FDA?
Hudson Rci Aquapak Humidifier Adaptor (K141353) received a 510(k) decision of Substantially Equivalent on August 1, 2014, 70 days after the submission was received.
What is the product code of K141353?
The FDA product code is BTT – Humidifier, Respiratory Gas, (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5450.