Submission Details
| 510(k) Number | K090935 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 02, 2009 |
| Decision Date | July 01, 2009 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Traditional
MINIME PEDIATRIC MASK
Jul 2009
Decision
90d
Days
Class 2
Risk
About This 510(k) Submission
K090935 is an FDA 510(k) clearance for the MINIME PEDIATRIC 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 July 1, 2009, 90 days after receiving the submission on April 2, 2009. 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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