Home / 510(k) Clearances / K831800

510(k) K831800

TEXAS INTERFACE PRESSURE EVALUATOR-TIPE by Tee-Kay Applied Technology — Product Code JFC

K831800 is an FDA 510(k) premarket notification submitted by Tee-Kay Applied Technology for the device "TEXAS INTERFACE PRESSURE EVALUATOR-TIPE". The FDA issued a decision of Substantially Equivalent on August 16, 1983. The device falls under product code JFC (System, Pressure Measurement, Intermittent), a Class I device regulated under 21 CFR 890.1600.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 1983
Date Received
May 23, 1983
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 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)
  • K915278 — CDG GAIT ANALYSES SYSTEM (April 7, 1992)
  • 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)
  • K823681 — MODEL ICPM & ACCESSORIES (February 23, 1983)

FDA data resources