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510(k) K862426

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

K862426 is an FDA 510(k) premarket notification submitted by Draeger Medical, Inc. for the device "PULSE OXIMETER". The FDA issued a decision of Substantially Equivalent on September 11, 1986. The device falls under product code DPZ (Oximeter, Ear), a Class II device regulated under 21 CFR 870.2710. Draeger Medical, Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by Draeger Medical, Inc.

  • K121886 — SAVINA 300 SAVINA 300, COUNTRY VARIANTS (August 8, 2014)
  • K133886 — PERSEUS A500 (June 20, 2014)
  • K121999 — GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE (February 28, 2013)
  • K103035 — SMARTPILOT VIEW MODEL MK04500 (March 28, 2012)
  • K082600 — OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DEVICE (MODEL 57 (November 26, 2008)
  • 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)

FDA data resources