Home / 510(k) Clearances / K810363

510(k) K810363

EAR OXIMETER by Bio-Tek Instruments, Inc. — Product Code DPZ

K810363 is an FDA 510(k) premarket notification submitted by Bio-Tek Instruments, Inc. for the device "EAR OXIMETER". The FDA issued a decision of Substantially Equivalent on February 27, 1981. The device falls under product code DPZ (Oximeter, Ear), a Class II device regulated under 21 CFR 870.2710. Bio-Tek Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1981
Date Received
February 11, 1981
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 Bio-Tek Instruments, Inc.

  • K973609 — IDA-4 AND IPT-MC (December 18, 1997)
  • K971273 — INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EF (October 8, 1997)
  • K961862 — MODELS IDA-2 PLUS AND IPT-1 (February 26, 1997)
  • K954391 — MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER (November 17, 1995)
  • K953710 — ELX808 AUTOMATED MICROPLATE READERS (October 25, 1995)
  • K953572 — ELX800UV (October 19, 1995)
  • K950104 — ELX800 AND EL800 AUTOMATED MICROPLATE READERS (March 21, 1995)
  • K942923 — CERES 900C & CERES UV900C (February 6, 1995)
  • K944257 — LIONHEART 3 MULTI-PARAMETER SIMULATOR (September 21, 1994)
  • K933519 — INDEX SPO2 SIMULATOR (September 1, 1994)

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)
  • K862426 — PULSE OXIMETER (September 11, 1986)
  • K845051 — VITALOG PMS-8 (May 15, 1985)
  • K850494 — OHMEDA BIOX 3700 PULSE OXIMETER (March 28, 1985)

FDA data resources