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510(k) K862426

PULSE OXIMETER by Draeger Medical, Inc. — Product Code DPZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1986
Date Received
June 26, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter, Ear
Device Class
Class II
Regulation Number
870.2710
Review Panel
AN
Submission Type

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  • K060705 — CARINA HOME (June 14, 2006)
  • K042607 — PRIMUS US (November 26, 2004)
  • K042419 — FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM (October 8, 2004)
  • K042276 — D-VAPOR (September 23, 2004)
  • K042086 — FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM (August 31, 2004)

Other clearances for product code DPZ

  • K042675 — FLEXI-STAT SP02 EAR SENSOR (December 6, 2004)
  • K040831 — DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500 (September 2, 2004)
  • K012333 — FLEXI-SITE SP02 EAR SENSOR (October 17, 2001)
  • K010718 — FLEXI-SITE SP02 EAR SENSOR (March 23, 2001)
  • K944760 — DURA-Y OXYGEN TRANSDUCER, EAR CLIP (October 17, 1994)
  • K942752 — MARQUETTE EAR PROBE SENSOR (September 2, 1994)
  • K914595 — PULSE RATE MONITOR (January 31, 1992)
  • K845051 — VITALOG PMS-8 (May 15, 1985)
  • K850494 — OHMEDA BIOX 3700 PULSE OXIMETER (March 28, 1985)
  • K810363 — EAR OXIMETER (February 27, 1981)