Puritan-Bennett Nasal CPAP Mask
FDA 510(k) K942246 · Puritan-Bennett
510(k) numberK942246
Submission
- Device name
- Puritan-Bennett Nasal CPAP Mask
- Applicant
- Puritan-Bennett
Lenexa, KS, US - Received
- May 9, 1994
- Decision date
- July 6, 1994
- 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 Puritan-Bennett Nasal CPAP Mask cleared by the FDA?
Puritan-Bennett Nasal CPAP Mask (K942246) received a 510(k) decision of Substantially Equivalent on July 6, 1994, 58 days after the submission was received.
What is the product code of K942246?
The FDA product code is BYE – Attachment, Breathing, Positive End Expiratory Pressure, a Class II (moderate risk) device regulated under 21 CFR 868.5965.