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510(k) K881284

COMPUTERIZED ORTHOPAEDIC PEDOTOPOGRAPHY MACHINE by Nathaniel Gould Diagnostics, Inc. — Product Code JFC

K881284 is an FDA 510(k) premarket notification submitted by Nathaniel Gould Diagnostics, Inc. for the device "COMPUTERIZED ORTHOPAEDIC PEDOTOPOGRAPHY MACHINE". The FDA issued a decision of Substantially Equivalent on July 21, 1988. 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
July 21, 1988
Date Received
March 25, 1988
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)
  • 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