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510(k) K924208

BIO-PROBE(R) BLOOD FLOW MONITORING SYST(TX-50/50P) by Medtronic Bio-Medicus, Inc. — Product Code DPT

K924208 is an FDA 510(k) premarket notification submitted by Medtronic Bio-Medicus, Inc. for the device "BIO-PROBE(R) BLOOD FLOW MONITORING SYST(TX-50/50P)". The FDA issued a decision of Substantially Equivalent on July 8, 1993. The device falls under product code DPT (Probe, Blood-Flow, Extravascular), a Class II device regulated under 21 CFR 870.2120. Medtronic Bio-Medicus, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1993
Date Received
August 20, 1992
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 Medtronic Bio-Medicus, Inc.

  • K973237 — CSS-CARDIOPLEGIA SAFETY SYSTEM (April 27, 1998)
  • K973011 — BPX80 BIO-PUMP (BPX80) (February 25, 1998)
  • K954501 — BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM (January 16, 1996)
  • K941922 — MEDSAT OXYGEN SATURATION SYSTEM (February 17, 1995)
  • K936091 — MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550M PUMP SPEED CONTROLLER (December 23, 1994)
  • K941921 — BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550 (July 20, 1994)
  • K926357 — MEDTRONIC BIO-MEDICUS HANDCRANK MODEL 150 (June 2, 1993)
  • K924206 — MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540E (May 7, 1993)
  • K924205 — MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550 (May 6, 1993)
  • K924642 — MEDTRONIC BIO-MEDICUS FEMORAL CANNULA/INTRODUCER (March 26, 1993)

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