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510(k) K910262

KELLER VITAL SIGNS MONITOR - KMS-890 by Keller Medical Specialties Products, Inc. — Product Code DSJ

K910262 is an FDA 510(k) premarket notification submitted by Keller Medical Specialties Products, Inc. for the device "KELLER VITAL SIGNS MONITOR - KMS-890". The FDA issued a decision of Substantially Equivalent on April 1, 1991. The device falls under product code DSJ (Alarm, Blood-Pressure), a Class II device regulated under 21 CFR 870.1100. Keller Medical Specialties Products, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 1991
Date Received
January 22, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alarm, Blood-Pressure
Device Class
Class II
Regulation Number
870.1100
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)
  • K914576 — KELLER CARDIAC MONITOR MEDIL KMS870 (December 30, 1991)
  • K903437 — DISPOS ACCESS EXTERNAL CARDIAC PACEMAKER (November 16, 1990)
  • K895987 — KELLER PULSE OXIMETER - KMS 850 (February 22, 1990)

Other clearances for product code DSJ

  • K190624 — EarlyVue VS30 (October 27, 2019)
  • K163649 — SureSigns VS3; SureSigns VS4 (March 31, 2017)
  • K151761 — SureSigns VS3, SureSigns VS4 (September 29, 2015)
  • K133961 — SURESIGNS VS3, SURESIGNS VS4 (June 26, 2014)
  • K960916 — SAMS 8000 CARDIOPLEGIA MONITOR (June 4, 1996)

FDA data resources