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510(k) K042675

FLEXI-STAT SP02 EAR SENSOR by Elekon Industries U.S.A., Inc. — Product Code DPZ

K042675 is an FDA 510(k) premarket notification submitted by Elekon Industries U.S.A., Inc. for the device "FLEXI-STAT SP02 EAR SENSOR". The FDA issued a decision of Substantially Equivalent on December 6, 2004. The device falls under product code DPZ (Oximeter, Ear), a Class II device regulated under 21 CFR 870.2710. Elekon Industries U.S.A., Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2004
Date Received
September 29, 2004
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 Elekon Industries U.S.A., Inc.

  • K042705 — DISPOSABLE NON-ADHESIVE SPO2 SENSORS (December 29, 2004)
  • K042704 — REUSABLE FINGER CLIP SPO2 SENSORS (November 26, 2004)
  • K041522 — FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS (September 14, 2004)
  • K041647 — FLEXI-STAT REUSABLE FINGER CLIP SPO2 SENSORS (NELLCOR-COMPATIBLE),(BCI-COMPATIBL (September 2, 2004)
  • K041644 — FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMP (July 29, 2004)

Other clearances for product code DPZ

  • 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)
  • 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