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510(k) K002686

ACHIEVA VENTILATOR Y-ACH+E, ACHIEVA PS VENTILATOR Y-ACHPS+E, ACHIEVA PSO2 VENTILATOR Y-ACHPS02+E by Nellcor Puritan Bennett, Inc. — Product Code CBK

Clearance Details

Decision
ST ()
Decision Date
October 18, 2000
Date Received
August 28, 2000
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Facility Use
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

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  • K051352 — OXIMAX NPB-40 HANDHELD PULSE OXIMETER (August 11, 2005)
  • K050072 — GOODKNIGHT 425ST (June 13, 2005)
  • K033973 — OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR (December 13, 2004)
  • K030787 — SHILEY FLEXTRA TRACHEOSTOMY TUBE (November 14, 2003)
  • K030930 — OXIMAX SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N (May 23, 2003)

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