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510(k) K050088

QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZER by Neoprobe Corp. — Product Code DPW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2005
Date Received
January 13, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flowmeter, Blood, Cardiovascular
Device Class
Class II
Regulation Number
870.2100
Review Panel
CV
Submission Type

Other clearances by Neoprobe Corp.

  • 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)
  • K864263 — NEOPROBE PORTABLE RADIOISOTOPE DETECTOR (December 29, 1986)

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