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510(k) K944760

DURA-Y OXYGEN TRANSDUCER, EAR CLIP by Nellcor, Inc. — Product Code DPZ

K944760 is an FDA 510(k) premarket notification submitted by Nellcor, Inc. for the device "DURA-Y OXYGEN TRANSDUCER, EAR CLIP". The FDA issued a decision of Substantially Equivalent on October 17, 1994. The device falls under product code DPZ (Oximeter, Ear), a Class II device regulated under 21 CFR 870.2710. Nellcor, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 1994
Date Received
September 27, 1994
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 Nellcor, Inc.

  • K953472 — NELLCOR SYMPHONY N-3100 BLOOD PRESSURE MONITOR (October 20, 1995)
  • K952316 — NELLCOR SYMPHONY N-3000 PULSE OXIMETER (August 17, 1995)
  • K952222 — NELLCOR N-20PA PORTABLE PULSE OXIMETER (August 15, 1995)
  • K942347 — NELLCOR SYMPHONY PULSE OXIMETER MODEL N-3000 (May 12, 1995)
  • K945947 — NELLCOR SYMPHONY(TM) N-3100 BLOOD PRESSURE MONITOR AND CONNECTED TO THE NELLCOR (March 8, 1995)
  • K944400 — PEDI-CAP (September 27, 1994)
  • K915494 — NELLCOR STAT-CAP AIRWAY CO2 INDICATOR, MODEL N-60 (August 6, 1993)
  • K915699 — NELLCOR PORTABLE PULSE OXIMETER MODEL N-20 (May 27, 1993)
  • K913695 — NELLCOR(R) N-180 PULSE OXIMETER (November 13, 1991)
  • K904039 — REFLECTANCE SENSOR (RS-10) (December 27, 1990)

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)
  • K942752 — MARQUETTE EAR PROBE SENSOR (September 2, 1994)
  • K914595 — PULSE RATE MONITOR (January 31, 1992)
  • K862426 — PULSE OXIMETER (September 11, 1986)
  • 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