System 22 Valve
FDA 510(k) K950397 · Turnkey Intergration USA, Inc.
510(k) numberK950397
Submission
- Device name
- System 22 Valve
- Applicant
- Turnkey Intergration USA, Inc.
Indianapolis, IN, US - Received
- February 1, 1995
- Decision date
- April 14, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BYE – Attachment, Breathing, Positive End Expiratory Pressure
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5965
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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Questions and answers
When was System 22 Valve cleared by the FDA?
System 22 Valve (K950397) received a 510(k) decision of Substantially Equivalent on April 14, 1995, 72 days after the submission was received.
What is the product code of K950397?
The FDA product code is BYE – Attachment, Breathing, Positive End Expiratory Pressure, a Class II (moderate risk) device regulated under 21 CFR 868.5965.