Modified Sanders Bi-Papeasy
FDA 510(k) K883825 · Respironics, Inc.
510(k) numberK883825
Submission
- Device name
- Modified Sanders Bi-Papeasy
- Applicant
- Respironics, Inc.
Murrysville, PA, US - Received
- September 9, 1988
- Decision date
- December 8, 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 Modified Sanders Bi-Papeasy cleared by the FDA?
Modified Sanders Bi-Papeasy (K883825) received a 510(k) decision of Substantially Equivalent on December 8, 1988, 90 days after the submission was received.
What is the product code of K883825?
The FDA product code is BYE – Attachment, Breathing, Positive End Expiratory Pressure, a Class II (moderate risk) device regulated under 21 CFR 868.5965.