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510(k) K050072

GOODKNIGHT 425ST by Nellcor Puritan Bennett, Inc. — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2005
Date Received
January 12, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Non-Continuous (Respirator)
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type

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  • K052186 — NELLCOR OXIMAX PULSE OXIMETRY SENSONS (MAX-A, MAX-AL, MAX-N, MAX-I, MAX-P (November 10, 2005)
  • K051352 — OXIMAX NPB-40 HANDHELD PULSE OXIMETER (August 11, 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)
  • K023494 — NELLCOR INDGO MANUAL RESUSCITATOR (February 7, 2003)

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