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510(k) K873041

A-V RECORDER by Life Sciences Manufacturing, Inc. — Product Code DPT

K873041 is an FDA 510(k) premarket notification submitted by Life Sciences Manufacturing, Inc. for the device "A-V RECORDER". The FDA issued a decision of Substantially Equivalent on February 4, 1988. The device falls under product code DPT (Probe, Blood-Flow, Extravascular), a Class II device regulated under 21 CFR 870.2120. Life Sciences Manufacturing, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1988
Date Received
August 4, 1987
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 Life Sciences Manufacturing, Inc.

  • K910905 — SFA-II MICROPROCESSOR-CONTROLLED MODULE (July 24, 1991)
  • K903700 — IPG-II MODULE (January 16, 1991)
  • K896500 — CWD/PPG MODULE (July 18, 1990)
  • K900365 — PAG MICROPROCESSOR-CONTROLLED MODULE (July 18, 1990)
  • K895588 — PORTABLE AIR PLETHYSMOGRAPH (March 27, 1990)
  • K896528 — SFA MODULE (January 26, 1990)
  • K884624 — MVL/MODULAB WITH PVR MODULE (February 1, 1989)
  • K832679 — NON-INVASIVE CLINICAL VASCULAR LAB (January 3, 1984)
  • K822522 — CUTANEOUS PRESSURE PLETHYSMOGRAPH (September 28, 1982)
  • K811560 — AUTOMATED PHYSIOLOGIC PROFILE MONITOR (June 18, 1981)

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