Breathing Filter for Disposable Anesthesia Breathing Circuit
FDA 510(k) K002506 · Sims Portex, Inc.
510(k) numberK002506
Submission
- Device name
- Breathing Filter for Disposable Anesthesia Breathing Circuit
- Applicant
- Sims Portex, Inc.
Keene, NH, US - Received
- August 15, 2000
- Decision date
- December 14, 2000
- 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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Questions and answers
When was Breathing Filter for Disposable Anesthesia Breathing Circuit cleared by the FDA?
Breathing Filter for Disposable Anesthesia Breathing Circuit (K002506) received a 510(k) decision of Substantially Equivalent on December 14, 2000, 121 days after the submission was received.
What is the product code of K002506?
The FDA product code is CAH – Filter, Bacterial, Breathing-Circuit, a Class II (moderate risk) device regulated under 21 CFR 868.5260.