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FDA 510(k), K140929, Z1 CPAP SYSTEM
FDA 510(k), K140929, Z1 CPAP SYSTEM
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510(K) Number: K140929
Device Name: Z1 CPAP SYSTEM
Manufacturer: MAUREEN O'CONNELL
Device Classification Name: Ventilator, Non-Continuous (Respirator)
Regulation Number: BZD
Classification Product Code: KXA
Date Received: 04/09/2014
Decision Date: 10/17/2014
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
Device Name: Z1 CPAP SYSTEM
Manufacturer: MAUREEN O'CONNELL
Device Classification Name: Ventilator, Non-Continuous (Respirator)
Regulation Number: BZD
Classification Product Code: KXA
Date Received: 04/09/2014
Decision Date: 10/17/2014
Decision: Substantially Equivalent (SESE)
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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