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510(k) K861260

PEDABAROGRAPH by Biokinetics, Inc. — Product Code JFC

K861260 is an FDA 510(k) premarket notification submitted by Biokinetics, Inc. for the device "PEDABAROGRAPH". The FDA issued a decision of Substantially Equivalent on May 2, 1986. 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
May 2, 1986
Date Received
April 3, 1986
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)
  • K925258 — DYNAMIC PRESSURE MONITOR 2000M AND 2000C (March 9, 1993)
  • K925052 — QA PRESSURE MEASUREMENT SYSTEM (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)
  • K831800 — TEXAS INTERFACE PRESSURE EVALUATOR-TIPE (August 16, 1983)
  • K823681 — MODEL ICPM & ACCESSORIES (February 23, 1983)

FDA data resources