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510(k) K864263

NEOPROBE PORTABLE RADIOISOTOPE DETECTOR by Neoprobe Corp. — Product Code IZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1986
Date Received
October 29, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe, Uptake, Nuclear
Device Class
Class I
Regulation Number
892.1320
Review Panel
RA
Submission Type

Other clearances by Neoprobe Corp.

  • K050088 — QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZER (February 8, 2005)
  • K971167 — NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES (June 26, 1997)
  • K962319 — NEOPROBE 1000 GEN 1C PORTABLE RADIOISOTOPE DETECTOR & ACCESSORIES (September 13, 1996)
  • K942580 — NEOPROBE 1000 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES (February 9, 1995)
  • K915279 — NEOPROBE PORTABLE RADIOSCOPE DETECTOR (June 10, 1992)

Other clearances for product code IZD

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  • K123917 — DECLIPSESPECT VIEWER (January 25, 2013)
  • K101887 — CONFIDENT SURGERY SUITE 300, MODEL CSS300 (March 22, 2011)
  • K013751 — HANDHELD GAMMA FINDER (HGF) (February 6, 2002)
  • K983768 — MODIFICATION TO GAMMA GUIDANCE SYSTEM (July 2, 1999)
  • K982442 — C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK) (August 25, 1998)
  • K971167 — NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES (June 26, 1997)
  • K961321 — GAMMA GUIDANCE SYSTEM (February 10, 1997)
  • K962319 — NEOPROBE 1000 GEN 1C PORTABLE RADIOISOTOPE DETECTOR & ACCESSORIES (September 13, 1996)
  • K942580 — NEOPROBE 1000 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES (February 9, 1995)