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510(k) K911240

HEPCON HMS WITH BODY SURFACE AREA CALCULATION by Hemotech, Inc. — Product Code JOX

K911240 is an FDA 510(k) premarket notification submitted by Hemotech, Inc. for the device "HEPCON HMS WITH BODY SURFACE AREA CALCULATION". The FDA issued a decision of Substantially Equivalent on July 17, 1991. The device falls under product code JOX (Analyzer, Heparin, Automated), a Class II device regulated under 21 CFR 864.5680.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1991
Date Received
March 21, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Heparin, Automated
Device Class
Class II
Regulation Number
864.5680
Review Panel
HE
Submission Type

Other clearances for product code JOX

  • K111339 — HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) (June 8, 2011)
  • K102953 — HEPARIN DOSE RESPONSE CARTRIDGE (November 4, 2010)
  • K101271 — HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX (October 13, 2010)
  • K051040 — HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR (May 24, 2005)
  • K043080 — HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR (December 3, 2004)
  • K042070 — HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20 (October 1, 2004)
  • K993519 — RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOIN (January 14, 2000)
  • K922031 — HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL (July 21, 1992)
  • K894317 — HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS. (September 5, 1989)
  • K854377 — HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS (December 4, 1985)

FDA data resources