Submission Details
| 510(k) Number | K050994 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 19, 2005 |
| Decision Date | August 03, 2005 |
| Days to Decision | 106 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Traditional
AIRLIFE INFANT NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM
Aug 2005
Decision
106d
Days
Class 2
Risk
About This 510(k) Submission
K050994 is an FDA 510(k) clearance for the AIRLIFE INFANT NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Cardinalhealth (Mcgaw Park, US). The FDA issued a Cleared decision on August 3, 2005, 106 days after receiving the submission on April 19, 2005. 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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