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510(k) K880373

IONOMETER E-HK AND ACCESSORIES by Smash Ent., Inc. — Product Code GKF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1988
Date Received
January 27, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Hematocrit, Automated
Device Class
Class II
Regulation Number
864.5600
Review Panel
HE
Submission Type

Other clearances by Smash Ent., Inc.

  • K880857 — SYRINGE PUMP MS2000 (September 1, 1988)
  • K881162 — ENTERA* ENTERAL FEEDING BAG (June 3, 1988)
  • K870183 — IONOMETER EF AND ACCESSORIES (May 12, 1987)

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  • K981427 — STAT PROFILE M ANALYZER (May 12, 1998)
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  • K981425 — STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS (May 12, 1998)
  • K953519 — MICROSPIN 24 (November 3, 1995)
  • K915825 — MARATHON 6K GENERAL-PURPOSE CENTRIFUGE (March 11, 1992)
  • K915441 — MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE (January 8, 1992)
  • K904336 — NEW COBE SATURATION/HEMATOCRIT MONITOR (December 27, 1990)
  • K870860 — CHEMPRO 1000(TM) (April 14, 1987)