Submission Details
| 510(k) Number | K102317 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 16, 2010 |
| Decision Date | May 17, 2011 |
| Days to Decision | 274 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Traditional
IQ VENTILATION NASAL MASK
May 2011
Decision
274d
Days
Class 2
Risk
About This 510(k) Submission
K102317 is an FDA 510(k) clearance for the IQ VENTILATION NASAL MASK, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Sleepnet Corporation (Bonita Springs, US). The FDA issued a Cleared decision on May 17, 2011, 274 days after receiving the submission on August 16, 2010. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.
Device Classification
| Product Code | BZD — Ventilator, Non-continuous (respirator) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5905 |
Manufacturer
Similar Devices — BZD Ventilator, Non-continuous (respirator)
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