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510(k) K926191

SIGMA 7000 AND SIGMA70002 by Sigma — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 1993
Date Received
December 9, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by Sigma

  • K962239 — SMART ADJUSTER (SA201) (January 10, 1997)
  • K851738 — MCDB-105 MED. M6395, W/L-GLUTAMINE, 25M M HERPES & (May 15, 1985)
  • K851737 — MCDB-110 MED. M6520 W/L-GLUTAMINE-25M M HERPES & (May 15, 1985)
  • K830038 — SIGMA 7000-6000 INFUSION PUMPS (January 26, 1983)
  • K820038 — SIGMA 7000 (January 26, 1983)

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