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510(k) K912925

ULTRA PVD by Advanced Medical Products, Inc. — Product Code JAF

K912925 is an FDA 510(k) premarket notification submitted by Advanced Medical Products, Inc. for the device "ULTRA PVD". The FDA issued a decision of Substantially Equivalent on June 18, 1992. The device falls under product code JAF (Monitor, Ultrasonic, Nonfetal), a Class II device regulated under 21 CFR 892.1540. Advanced Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 1992
Date Received
July 3, 1991
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 by Advanced Medical Products, Inc.

  • K110979 — DERMAGRIP ULTRA POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES NON-STERILE, (October 20, 2011)
  • K000932 — ARACHNOPHLEBECTOMY NEEDLE (May 17, 2000)
  • K923995 — URODYNAMICS TUBING KITS #5161, #5150, #7170 (April 8, 1993)
  • K921426 — ULTRA PCI (October 5, 1992)
  • K915658 — SPECTRA ECG (June 10, 1992)
  • K896103 — MICRO FL 7400 AMBULATORY HOLTER/BP MONITOR (January 18, 1990)
  • K896102 — MICRO FD 7000 AMBULATORY BLOOD PRESSURE MONITOR (January 18, 1990)
  • K881905 — MODEL MICRO SI AMBULATORY ECG MONITOR (August 2, 1988)
  • K872508 — MODEL MICRO FD+ AMBULATORY ECG MONITOR (September 25, 1987)
  • K870538 — MODEL 192 PRINTER (April 23, 1987)

Other clearances for product code JAF

  • K242487 — Laminar P1 (LDH-HW-001) (December 13, 2024)
  • 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)
  • K060064 — STETHOFLUX (April 10, 2006)
  • K052067 — DOPPLER GUIDED PROCTOSCOPE, MODEL 500H (August 29, 2005)

FDA data resources