Submission Details
| 510(k) Number | K110713 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 15, 2011 |
| Decision Date | September 12, 2011 |
| Days to Decision | 181 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Traditional
WATERPAP VALVE
Sep 2011
Decision
181d
Days
Class 2
Risk
About This 510(k) Submission
K110713 is an FDA 510(k) clearance for the WATERPAP VALVE, a Attachment, Breathing, Positive End Expiratory Pressure (Class II — Special Controls, product code BYE), submitted by Airways Development, LLC (Cedar Knolls, US). The FDA issued a Cleared decision on September 12, 2011, 181 days after receiving the submission on March 15, 2011. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5965.
Device Classification
| Product Code | BYE — Attachment, Breathing, Positive End Expiratory Pressure |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5965 |
Manufacturer
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