FDA 510(k), K974303, INFANT FLOW SYSTEM

FDA 510(k), K974303, INFANT FLOW SYSTEM

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510(K) Number: K974303
Device Name: INFANT FLOW SYSTEM
Manufacturer: SENSORMEDICS CORP.
Device Classification Name: Ventilator, Non-Continuous (Respirator)
Regulation Number: 868.5905
Classification Product Code: BZD
Date Received: 11/17/1997
Decision Date: 01/30/1998
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. Learn more about Fast-Track Requests here.

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