Silenzio Plus Continuous Positive Airway Pressure System
FDA 510(k) K962492 · Nidek Medical Products, Inc.
510(k) numberK962492
Submission
- Device name
- Silenzio Plus Continuous Positive Airway Pressure System
- Applicant
- Nidek Medical Products, Inc.
Birmingham, AL, US - Received
- June 26, 1996
- Decision date
- January 23, 1997
- 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 Silenzio Plus Continuous Positive Airway Pressure System cleared by the FDA?
Silenzio Plus Continuous Positive Airway Pressure System (K962492) received a 510(k) decision of Substantially Equivalent on January 23, 1997, 211 days after the submission was received.
What is the product code of K962492?
The FDA product code is BYE – Attachment, Breathing, Positive End Expiratory Pressure, a Class II (moderate risk) device regulated under 21 CFR 868.5965.