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510(k) K844736

ISIS by Oxford Medilog, Inc. — Product Code LDK

K844736 is an FDA 510(k) premarket notification submitted by Oxford Medilog, Inc. for the device "ISIS". The FDA issued a decision of Substantially Equivalent on March 21, 1985. The device falls under product code LDK (Device, Sensing, Optical Contour), a Class U device. Oxford Medilog, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1985
Date Received
December 5, 1984
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 Oxford Medilog, Inc.

  • K923737 — MODEL MEDILOG RAPIDE (January 5, 1994)
  • K920295 — MEDILOG EXCEL ECG ANALYSIS SYSTEM (MODIFIED) (August 18, 1992)
  • K912890 — MODEL SONICAID AXIS (January 9, 1992)
  • K912639 — SONICAID TEAM (December 31, 1991)
  • K904763 — MENTOR EEG SYSTEM (April 10, 1991)
  • K902690 — SONICAID MODEL MERIDIAN 800 (February 5, 1991)
  • K895909 — SONICAID MODEL VASOFLO 4 (July 9, 1990)
  • K896535 — MEDILOG OPTIMA (January 18, 1990)
  • K891383 — MEDILOG 9200 EEG REPLAY/ANALYSIS SYSTEM (June 1, 1989)
  • K890330 — MEDILOG 6000-FD REPORT GENERATOR (April 20, 1989)

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)
  • K800591 — CONTOUROGRAPH M-500 (April 2, 1980)

FDA data resources