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510(k) K982331

KELLER PULSE OXIMETER, MODEL 850+ by Keller Medical Specialties Products, Inc. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1998
Date Received
July 2, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
Submission Type

Other clearances by Keller Medical Specialties Products, Inc.

  • K990648 — KELLER VITAL SIGNS MONITOR, KMS 890+ (August 10, 1999)
  • K914576 — KELLER CARDIAC MONITOR MEDIL KMS870 (December 30, 1991)
  • K910262 — KELLER VITAL SIGNS MONITOR - KMS-890 (April 1, 1991)
  • K903437 — DISPOS ACCESS EXTERNAL CARDIAC PACEMAKER (November 16, 1990)
  • K895987 — KELLER PULSE OXIMETER - KMS 850 (February 22, 1990)

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