Home / 510(k) Clearances / K963703

510(k) K963703

ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000) by International Biophysics Corp. — Product Code DPT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1998
Date Received
September 16, 1996
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 International Biophysics Corp.

  • K072688 — LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY1000 (January 11, 2008)
  • K030181 — INTERNATIONAL BIOPHYSICS CORPORATION (IBC) LASER PEEL SYSTEM (April 17, 2003)
  • K992657 — IBC VRV, MODEL 1350 (February 18, 2000)
  • K992785 — IBC FLOGUARD, MODEL 6050 (January 14, 2000)
  • K992964 — IBC VENT VALVE, MODEL 1400 (November 19, 1999)
  • K983272 — IBC FLOPUMP, MODEL 6000 (March 24, 1999)
  • K963756 — IBC CARDIAC SUCTION WARD (November 14, 1997)
  • K963698 — CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4 (March 20, 1997)
  • K955379 — IBC GAS CELL COMPONENTS (1/2, 3/8, 1/4) (May 14, 1996)
  • K955380 — IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4) (May 14, 1996)

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)