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510(k) K792015

P-2 ULTRASONIC ARTERIOGRAPH by D. E. Hokanson, Inc. — Product Code DPT

K792015 is an FDA 510(k) premarket notification submitted by D. E. Hokanson, Inc. for the device "P-2 ULTRASONIC ARTERIOGRAPH". The FDA issued a decision of Substantially Equivalent on December 4, 1979. The device falls under product code DPT (Probe, Blood-Flow, Extravascular), a Class II device regulated under 21 CFR 870.2120. D. E. Hokanson, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1979
Date Received
October 5, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe, Blood-Flow, Extravascular
Device Class
Class II
Regulation Number
870.2120
Review Panel
CV
Submission Type

Other clearances by D. E. Hokanson, Inc.

  • K041689 — POLYURETHANE BLOOD PRESSURE CUFFS (August 6, 2004)
  • K033156 — OB1 OBSTETRICAL DOPPLER (December 9, 2003)
  • K023707 — A16 BLOOD FLOW MEASUREMENT SYSTEM (February 12, 2003)
  • K982707 — EC6 PLETHYSMOGRAPH (August 26, 1998)
  • K973426 — ANS 2000 ECG MONITOR AND RESPIRATION PACER (August 12, 1998)
  • K970570 — NIVP3 (WINDOWS VERSION OF NIVP (October 3, 1997)
  • K932852 — NON INVASIVE VASCULAR PROGRAM (February 4, 1994)
  • K932812 — EC 5R PLETHYSMOGRAPH (January 13, 1994)
  • K932851 — DISPOSABLE PENILE BLOOD PRESSURE CUFFS (November 15, 1993)
  • K905367 — E-20 RAPID CUFF INFLATOR (March 6, 1991)

Other clearances for product code DPT

  • K233076 — Laser Speckle Imaging System (RFLSI CZW) (May 28, 2024)
  • K163339 — SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0 (August 17, 2017)
  • K152749 — moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared (May 12, 2016)
  • K142932 — Deltex Medical KDP72 Doppler Probe (January 22, 2015)
  • K132730 — BIO-PROBE DISPOSABLE INSERT WITH; BALANCE BIOSURFACE, CARMEDA BIOACTIVE SURFACE (May 30, 2014)
  • K133903 — BIO-PROBE TRANSDUCER (ADULT) (April 10, 2014)
  • K132163 — MOORLDLS-BI LASER DOPPLER BURNS IMAGER (January 29, 2014)
  • K124049 — DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM (April 18, 2013)
  • K123216 — AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA ARM), AIMAGO EASY LDI (February 7, 2013)
  • K122943 — MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER (January 3, 2013)

FDA data resources