Kendall Sheridan CPAP System
FDA 510(k) K953511 · Kendall Healthcare Products Co. Div.Of Tyco Health
510(k) numberK953511
Submission
- Device name
- Kendall Sheridan CPAP System
- Applicant
- Kendall Healthcare Products Co. Div.Of Tyco Health
Mansfield, MA, US - Received
- July 26, 1995
- Decision date
- October 26, 1995
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 Kendall Sheridan CPAP System cleared by the FDA?
Kendall Sheridan CPAP System (K953511) received a 510(k) decision of Unknown on October 26, 1995, 92 days after the submission was received.
What is the product code of K953511?
The FDA product code is BYE – Attachment, Breathing, Positive End Expiratory Pressure, a Class II (moderate risk) device regulated under 21 CFR 868.5965.