Sleep Apnea Nasal CPAP System
FDA 510(k) K871693 · Puritan Bennett Corp.
510(k) numberK871693
Submission
- Device name
- Sleep Apnea Nasal CPAP System
- Applicant
- Puritan Bennett Corp.
Overland Park, KS, US - Received
- April 29, 1987
- Decision date
- September 15, 1987
- 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 Sleep Apnea Nasal CPAP System cleared by the FDA?
Sleep Apnea Nasal CPAP System (K871693) received a 510(k) decision of Substantially Equivalent on September 15, 1987, 139 days after the submission was received.
What is the product code of K871693?
The FDA product code is BYE – Attachment, Breathing, Positive End Expiratory Pressure, a Class II (moderate risk) device regulated under 21 CFR 868.5965.