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510(k) K012333

FLEXI-SITE SP02 EAR SENSOR by Epic Medical Equipment Services, Inc. — Product Code DPZ

K012333 is an FDA 510(k) premarket notification submitted by Epic Medical Equipment Services, Inc. for the device "FLEXI-SITE SP02 EAR SENSOR". The FDA issued a decision of Substantially Equivalent on October 17, 2001. The device falls under product code DPZ (Oximeter, Ear), a Class II device regulated under 21 CFR 870.2710. Epic Medical Equipment Services, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2001
Date Received
July 24, 2001
Clearance Type
Special
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 Epic Medical Equipment Services, Inc.

  • K002848 — SPO2 WRAP SENSOR (May 24, 2001)
  • K010718 — FLEXI-SITE SP02 EAR SENSOR (March 23, 2001)
  • K002223 — EPIC SPO2 FINGER SENSOR, MODEL E412-20 (August 22, 2000)
  • K000831 — STAT-SHELL DISPOSABLE SP02 SENSOR (June 5, 2000)
  • K992811 — TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING (January 18, 2000)
  • K992211 — SPO2 WRAP SENSOR (December 22, 1999)
  • K992092 — STAT-SHELL DISPOSABLE SPO2 SENSOR (December 22, 1999)
  • K990082 — EPIC SPO2 FINGER SENSOR, MODEL E403-09, E412-09 AND EPIC OXIMETER CABLE, MODEL E (April 9, 1999)
  • K970098 — E100 SERIES SPO2 SENSORS (April 30, 1998)
  • K965172 — OXIMETER PRE-AMP CABLE (July 16, 1997)

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)
  • 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)
  • 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