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FDA 510(k), K121597, ESON NASAL MASK
FDA 510(k), K121597, ESON NASAL MASK
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510(K) Number: K121597
Device Name: ESON NASAL MASK
Manufacturer: FISHER & PAYKEL HEALTHCARE LIMITED
Device Classification Name: ventilator, non-continuous (respirator)
Regulation Number: 868.5905
Classification Product Code: BZD
Date Received: 05/31/2012
Decision Date: 10/02/2012
Regulation Medical Specialty: Anesthesiology
Device Name: ESON NASAL MASK
Manufacturer: FISHER & PAYKEL HEALTHCARE LIMITED
Device Classification Name: ventilator, non-continuous (respirator)
Regulation Number: 868.5905
Classification Product Code: BZD
Date Received: 05/31/2012
Decision Date: 10/02/2012
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
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.
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