Portex Thermovent Hepa Hme Breathing Filter with CO2 Port (Sterile and Non-Sterile)
FDA 510(k) K032716 · Portex , Ltd.
510(k) numberK032716
Submission
- Device name
- Portex Thermovent Hepa Hme Breathing Filter with CO2 Port (Sterile and Non-Sterile)
- Applicant
- Portex , Ltd.
Hythe, Kent, GB - Received
- September 2, 2003
- Decision date
- November 28, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAH – Filter, Bacterial, Breathing-Circuit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5260
- Specialty
- Anesthesiology
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| K221250 | EasyOne FilterCAH · Traditional | Ndd Medizintechnik AG | 11/22/2022SE |
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Questions and answers
When was Portex Thermovent Hepa Hme Breathing Filter with CO2 Port (Sterile and Non-Sterile) cleared by the FDA?
Portex Thermovent Hepa Hme Breathing Filter with CO2 Port (Sterile and Non-Sterile) (K032716) received a 510(k) decision of Substantially Equivalent on November 28, 2003, 87 days after the submission was received.
What is the product code of K032716?
The FDA product code is CAH – Filter, Bacterial, Breathing-Circuit, a Class II (moderate risk) device regulated under 21 CFR 868.5260.