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510(k) K845051

VITALOG PMS-8 by Vitalog Corp. — Product Code DPZ

K845051 is an FDA 510(k) premarket notification submitted by Vitalog Corp. for the device "VITALOG PMS-8". The FDA issued a decision of Substantially Equivalent on May 15, 1985. The device falls under product code DPZ (Oximeter, Ear), a Class II device regulated under 21 CFR 870.2710. Vitalog Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1985
Date Received
December 19, 1984
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 Vitalog Corp.

  • K874198 — VITALOG HMS-3000 (March 22, 1988)
  • K871813 — VITALOG PMS-8 (MODIFICATION) (November 23, 1987)
  • K812739 — VITALOG PMS-8 MONITOR (December 29, 1981)

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)
  • K850494 — OHMEDA BIOX 3700 PULSE OXIMETER (March 28, 1985)
  • K810363 — EAR OXIMETER (February 27, 1981)

FDA data resources