FDA 510(k), K041662, APNEA RISK EVALUATION SYSTEM (ARES)

FDA 510(k), K041662, APNEA RISK EVALUATION SYSTEM (ARES)

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510(K) Number: K041662
Device Name: APNEA RISK EVALUATION SYSTEM (ARES)
Manufacturer: ADVANCED BRAIN MONITORING, INC.
Device Classification Name: ventilatory effort recorder
Regulation Number: 868.2375
Classification Product Code: MNR
Date Received: 06/18/2004
Decision Date: 10/14/2004
Regulation Medical Specialty: Anesthesiology
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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