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510(k) K051352

OXIMAX NPB-40 HANDHELD PULSE OXIMETER by Nellcor Puritan Bennett, Inc. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 2005
Date Received
May 24, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
Submission Type

Other clearances by Nellcor Puritan Bennett, Inc.

  • K070899 — PURITAN BENNETT LEGENDAIR XL2 (December 13, 2007)
  • K070408 — DURAMAX REUSABLE OXIMETRY SENSOR (May 25, 2007)
  • K060576 — NELLCOR OXIMAX N-600X PULSE OXIMETER (August 14, 2006)
  • K051271 — OXIMAX NEOMAX ADHESIVE FOREHEAD REFLECTANCE OXIMETRY SENSOR (January 10, 2006)
  • K052186 — NELLCOR OXIMAX PULSE OXIMETRY SENSONS (MAX-A, MAX-AL, MAX-N, MAX-I, MAX-P (November 10, 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)
  • K023494 — NELLCOR INDGO MANUAL RESUSCITATOR (February 7, 2003)

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