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510(k) K110628

SIMPLEABI by Newman Medical — Product Code JAF

K110628 is an FDA 510(k) premarket notification submitted by Newman Medical for the device "SIMPLEABI". The FDA issued a decision of Substantially Equivalent on May 12, 2011. 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
May 12, 2011
Date Received
March 3, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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

  • K242487 — Laminar P1 (LDH-HW-001) (December 13, 2024)
  • K141657 — THD REVOLUTION (February 24, 2015)
  • 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)
  • K060064 — STETHOFLUX (April 10, 2006)
  • K052067 — DOPPLER GUIDED PROCTOSCOPE, MODEL 500H (August 29, 2005)
  • K010521 — NICOLET VERSALAB (March 9, 2001)

FDA data resources