Water Column Relief Valve
FDA 510(k) K904398 · Icn Pharmaceuticals, Inc.
510(k) numberK904398
Submission
- Device name
- Water Column Relief Valve
- Applicant
- Icn Pharmaceuticals, Inc.
Costa Mesa, CA, US - Received
- September 25, 1990
- Decision date
- July 9, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 Water Column Relief Valve cleared by the FDA?
Water Column Relief Valve (K904398) received a 510(k) decision of Substantially Equivalent on July 9, 1991, 287 days after the submission was received.
What is the product code of K904398?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.