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510(k) K972698

TOF-WATCH by Organon Teknika Corp. — Product Code KOI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 1997
Date Received
July 18, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Peripheral, Electric
Device Class
Class II
Regulation Number
868.2775
Review Panel
AN
Submission Type

Other clearances by Organon Teknika Corp.

  • K003104 — BACT/ALERT CSR (October 20, 2000)
  • K000492 — MDA D-DIMER (June 7, 2000)
  • K000378 — BACT/ALERT MB CULTURE BOTTLE (March 2, 2000)
  • K994343 — BACT/ALERT SV (February 10, 2000)
  • K993423 — BACT/ALERT SA (December 15, 1999)
  • K993576 — BACT/ALERT MP PROCESS BOTTLE (December 14, 1999)
  • K993421 — BACT/ALERT SN (December 14, 1999)
  • K992432 — BACT/ALERT FN (September 24, 1999)
  • K983762 — NUCLISENS CMV PP67 (September 15, 1999)
  • K992401 — BACT/ALERT PF (September 3, 1999)

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  • K220530 — Tetragraph Neuromuscular Transmission Monitor (August 17, 2022)
  • K220976 — Life Scope PT BSM-1700 Series Bedside Monitor (July 21, 2022)
  • K212434 — Neuromuscular Transmission Monitor TOF3D (May 5, 2022)
  • K213316 — Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM (December 29, 2021)
  • K201949 — Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scop (May 2, 2021)
  • K192958 — TwitchView System (April 2, 2020)
  • K190795 — Tetragraph Neuromuscular Transmission Monitor (October 18, 2019)