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510(k) K914576

KELLER CARDIAC MONITOR MEDIL KMS870 by Keller Medical Specialties Products, Inc. — Product Code DRT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1991
Date Received
October 15, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

Other clearances by Keller Medical Specialties Products, Inc.

  • K990648 — KELLER VITAL SIGNS MONITOR, KMS 890+ (August 10, 1999)
  • K982331 — KELLER PULSE OXIMETER, MODEL 850+ (September 11, 1998)
  • 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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