Quadrasorb Filter
FDA 510(k) K923661 · Union Broach, Div. Moyco Industries, Inc.
510(k) numberK923661
Submission
- Device name
- Quadrasorb Filter
- Applicant
- Union Broach, Div. Moyco Industries, Inc.
Emigsville, PA, US - Received
- July 22, 1992
- Decision date
- October 20, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 Quadrasorb Filter cleared by the FDA?
Quadrasorb Filter (K923661) received a 510(k) decision of Substantially Equivalent on October 20, 1992, 90 days after the submission was received.
What is the product code of K923661?
The FDA product code is CAH – Filter, Bacterial, Breathing-Circuit, a Class II (moderate risk) device regulated under 21 CFR 868.5260.