FDA 510(k), K010739, WATCH-PAT 100

FDA 510(k), K010739, WATCH-PAT 100

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510(K) Number: K010739
Device Name: WATCH-PAT 100
Manufacturer: ITAMAR MEDICAL (C.M.) 1997 LTD.
Device Classification Name: ventilatory effort recorder
Regulation Number: 868.2375
Classification Product Code: MNR
Date Received: 03/12/2001
Decision Date: 11/06/2001
Regulation Medical Specialty: Anesthesiology
  • 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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