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FDA 510(k), K180407, Smartinhaler
FDA 510(k), K180407, Smartinhaler
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510(K) Number: K180407
Device Name: Smartinhaler
Manufacturer: Adherium (NZ) Ltd
Device Classification Name: nebulizer (direct patient interface)
Regulation Number: 868.5630
Classification Product Code: CAF
Date Received: 02/14/2018
Decision Date: 07/25/2018
Regulation Medical Specialty: Anesthesiology
Device Name: Smartinhaler
Manufacturer: Adherium (NZ) Ltd
Device Classification Name: nebulizer (direct patient interface)
Regulation Number: 868.5630
Classification Product Code: CAF
Date Received: 02/14/2018
Decision Date: 07/25/2018
Regulation Medical Specialty: Anesthesiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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