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510(k) K060064

STETHOFLUX by Odvi — Product Code JAF

K060064 is an FDA 510(k) premarket notification submitted by Odvi for the device "STETHOFLUX". The FDA issued a decision of Substantially Equivalent on April 10, 2006. The device falls under product code JAF (Monitor, Ultrasonic, Nonfetal), a Class II device regulated under 21 CFR 892.1540.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2006
Date Received
January 9, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Ultrasonic, Nonfetal
Device Class
Class II
Regulation Number
892.1540
Review Panel
RA
Submission Type

Other clearances for product code JAF

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  • K141657 — THD REVOLUTION (February 24, 2015)
  • K110628 — SIMPLEABI (May 12, 2011)
  • K093393 — LIFEDOP MODEL 300ABI (December 24, 2009)
  • K090009 — THD SLIDE ONE (January 28, 2009)
  • K081429 — THD SLIDE (July 30, 2008)
  • K070815 — THD (June 20, 2007)
  • K063600 — VISTA AVS (December 19, 2006)
  • K052067 — DOPPLER GUIDED PROCTOSCOPE, MODEL 500H (August 29, 2005)
  • K010521 — NICOLET VERSALAB (March 9, 2001)

FDA data resources