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510(k) K915278

CDG GAIT ANALYSES SYSTEM by Wrm Computers — Product Code JFC

K915278 is an FDA 510(k) premarket notification submitted by Wrm Computers for the device "CDG GAIT ANALYSES SYSTEM". The FDA issued a decision of Substantially Equivalent on April 7, 1992. The device falls under product code JFC (System, Pressure Measurement, Intermittent), a Class I device regulated under 21 CFR 890.1600. Wrm Computers has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 1992
Date Received
November 25, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Pressure Measurement, Intermittent
Device Class
Class I
Regulation Number
890.1600
Review Panel
PM
Submission Type

Other clearances by Wrm Computers

Other clearances for product code JFC

  • K924705 — FORCE SENSING ARRAY (May 12, 1993)
  • K925052 — QA PRESSURE MEASUREMENT SYSTEM (March 9, 1993)
  • K925258 — DYNAMIC PRESSURE MONITOR 2000M AND 2000C (March 9, 1993)
  • K914776 — OXFORD PRESSURE MONITOR/TALLEY PRESSURE MONITOR (December 19, 1991)
  • K913510 — MECHANICAL SHAPE SENSOR (September 23, 1991)
  • K881284 — COMPUTERIZED ORTHOPAEDIC PEDOTOPOGRAPHY MACHINE (July 21, 1988)
  • K882139 — 2P-QDA FOOT PRESSURE SYSTEMS REAL TIME (June 22, 1988)
  • K861260 — PEDABAROGRAPH (May 2, 1986)
  • K831800 — TEXAS INTERFACE PRESSURE EVALUATOR-TIPE (August 16, 1983)
  • K823681 — MODEL ICPM & ACCESSORIES (February 23, 1983)

FDA data resources