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510(k) K020754

NICOLET PIONEER TC8080 by Nicolet Biomedical — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 2003
Date Received
March 7, 2002
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Device Class
Class II
Regulation Number
892.1550
Review Panel
RA
Submission Type

Other clearances by Nicolet Biomedical

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  • K013281 — VERSALAB APM (April 18, 2002)
  • K020955 — NICOLET ELECTROCAUTERY DETECTOR (April 17, 2002)
  • K013419 — NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM (December 20, 2001)
  • K011823 — BIOREHAB SYSTEM (September 6, 2001)
  • K011818 — STERILE EMG ELECTRODES (September 6, 2001)
  • K011135 — GSI AUDERA (July 26, 2001)
  • K010019 — STERILE SUBDERMAL NEEDLE ELECTRODES (March 19, 2001)

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