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FDA 510(k), K161579, Watch-PAT200U
FDA 510(k), K161579, Watch-PAT200U
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510(K) Number: K161579
Device Name: Watch-PAT200U
Manufacturer: ITAMAR MEDICAL, LTD.
Device Classification Name: Ventilatory Effort Recorder
Regulation Number: 868.2375
Classification Product Code: MNR
Date Received: 06/07/2016
Decision Date: 02/24/2017
Regulation Medical Specialty: Anesthesiology
Device Name: Watch-PAT200U
Manufacturer: ITAMAR MEDICAL, LTD.
Device Classification Name: Ventilatory Effort Recorder
Regulation Number: 868.2375
Classification Product Code: MNR
Date Received: 06/07/2016
Decision Date: 02/24/2017
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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