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FDA 510(k), K010156, SLEEP PAT 200 DEVICE
FDA 510(k), K010156, SLEEP PAT 200 DEVICE
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510(K) Number: K010156
Device Name: SLEEP PAT 200 DEVICE
Manufacturer: ITAMAR MEDICAL (C.M.) 1997 LTD.
Device Classification Name: ventilatory effort recorder
Regulation Number: 868.2375
Classification Product Code: MNR
Date Received: 01/16/2001
Decision Date: 06/19/2002
Regulation Medical Specialty: Anesthesiology
Device Name: SLEEP PAT 200 DEVICE
Manufacturer: ITAMAR MEDICAL (C.M.) 1997 LTD.
Device Classification Name: ventilatory effort recorder
Regulation Number: 868.2375
Classification Product Code: MNR
Date Received: 01/16/2001
Decision Date: 06/19/2002
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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