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510(k) K800591

CONTOUROGRAPH M-500 by Bio-Tek Instruments, Inc. — Product Code LDK

K800591 is an FDA 510(k) premarket notification submitted by Bio-Tek Instruments, Inc. for the device "CONTOUROGRAPH M-500". The FDA issued a decision of Substantially Equivalent on April 2, 1980. The device falls under product code LDK (Device, Sensing, Optical Contour), a Class U device. Bio-Tek Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 1980
Date Received
March 17, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Sensing, Optical Contour
Device Class
Class U
Regulation Number
Review Panel
PM
Submission Type

Other clearances by Bio-Tek Instruments, Inc.

  • K973609 — IDA-4 AND IPT-MC (December 18, 1997)
  • K971273 — INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EF (October 8, 1997)
  • K961862 — MODELS IDA-2 PLUS AND IPT-1 (February 26, 1997)
  • K954391 — MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER (November 17, 1995)
  • K953710 — ELX808 AUTOMATED MICROPLATE READERS (October 25, 1995)
  • K953572 — ELX800UV (October 19, 1995)
  • K950104 — ELX800 AND EL800 AUTOMATED MICROPLATE READERS (March 21, 1995)
  • K942923 — CERES 900C & CERES UV900C (February 6, 1995)
  • K944257 — LIONHEART 3 MULTI-PARAMETER SIMULATOR (September 21, 1994)
  • K933519 — INDEX SPO2 SIMULATOR (September 1, 1994)

Other clearances for product code LDK

  • K230463 — NSite Scoliosis Assessment App (November 15, 2023)
  • K232023 — Momentum Spine (October 4, 2023)
  • K183485 — CryoVizion System (August 28, 2019)
  • K923792 — QUANTEC SPINAL MEASUEMENT SYSTEM (April 20, 1994)
  • K860225 — METRICOM (February 11, 1986)
  • K851133 — TERRAN BIOMECHANICAL ANALYSIS SYSTEM (June 19, 1985)
  • K844736 — ISIS (March 21, 1985)

FDA data resources