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FDA 510(k), K140211, ULTRASONIC MESH NEBULIZER
FDA 510(k), K140211, ULTRASONIC MESH NEBULIZER
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510(K) Number: K140211
Device Name: ULTRASONIC MESH NEBULIZER
Manufacturer: GUENTER GINSBERG
Device Classification Name: Nebulizer (Direct Patient Interface)
Regulation Number: CAF
Classification Product Code: 01/28/2014
Date Received: 05/30/2014
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
Device Name: ULTRASONIC MESH NEBULIZER
Manufacturer: GUENTER GINSBERG
Device Classification Name: Nebulizer (Direct Patient Interface)
Regulation Number: CAF
Classification Product Code: 01/28/2014
Date Received: 05/30/2014
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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