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510(k) K914776

OXFORD PRESSURE MONITOR/TALLEY PRESSURE MONITOR by Talley Group, Ltd. — Product Code JFC

K914776 is an FDA 510(k) premarket notification submitted by Talley Group, Ltd. for the device "OXFORD PRESSURE MONITOR/TALLEY PRESSURE MONITOR". The FDA issued a decision of Substantially Equivalent on December 19, 1991. The device falls under product code JFC (System, Pressure Measurement, Intermittent), a Class I device regulated under 21 CFR 890.1600. Talley Group, Ltd. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 1991
Date Received
October 23, 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 Talley Group, Ltd.

  • K151263 — Venturi Gauze Wound Care Sets with Portal Drain (February 19, 2016)
  • K143004 — VENTURI MiNO TG600/14 (January 5, 2016)
  • K914775 — TALLEY MICRO SYSTEM/TALLEY RIPPLEBED (April 10, 1992)
  • K914774 — MULTIPULSE SEQUENTIAL COMPRESSION UNIT (February 11, 1992)
  • K914780 — TALLEY SD.500 SKIN PRESSURE EVALUATOR (December 19, 1991)

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)
  • 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