FDA 510(k), K091461, BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE

FDA 510(k), K091461, BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE

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510(K) Number: K091461
Device Name: BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE
Manufacturer: CARDIOPULMONARY CORP.
Device Classification Name: accessory to continuous ventilator (respirator)
Regulation Number: 868.5895
Classification Product Code: MOD
Date Received: 05/18/2009
Decision Date: 08/14/2009
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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