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FDA 510(k), K160112, Besmed PEEP Valve
FDA 510(k), K160112, Besmed PEEP Valve
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510(K) Number: K160112
Device Name: Besmed PEEP Valve
Manufacturer: BESMED HEALTH BUSINESS CORP.
Device Classification Name: attachment, breathing, positive end expiratory pressure
Regulation Number: 868.5965
Classification Product Code: BYE
Date Received: 01/19/2016
Decision Date: 04/29/2016
Regulation Medical Specialty: Anesthesiology
Device Name: Besmed PEEP Valve
Manufacturer: BESMED HEALTH BUSINESS CORP.
Device Classification Name: attachment, breathing, positive end expiratory pressure
Regulation Number: 868.5965
Classification Product Code: BYE
Date Received: 01/19/2016
Decision Date: 04/29/2016
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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