P.E.E.P. Valve
FDA 510(k) K882219 · Life Support Products, Inc.
510(k) numberK882219
Submission
- Device name
- P.E.E.P. Valve
- Applicant
- Life Support Products, Inc.
Irvine, CA, US - Received
- May 26, 1988
- Decision date
- August 30, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 P.E.E.P. Valve cleared by the FDA?
P.E.E.P. Valve (K882219) received a 510(k) decision of Substantially Equivalent on August 30, 1988, 96 days after the submission was received.
What is the product code of K882219?
The FDA product code is BYE – Attachment, Breathing, Positive End Expiratory Pressure, a Class II (moderate risk) device regulated under 21 CFR 868.5965.