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510(k) K914780

TALLEY SD.500 SKIN PRESSURE EVALUATOR by Talley Group, Ltd. — Product Code IKE

K914780 is an FDA 510(k) premarket notification submitted by Talley Group, Ltd. for the device "TALLEY SD.500 SKIN PRESSURE EVALUATOR". The FDA issued a decision of Substantially Equivalent on December 19, 1991. The device falls under product code IKE (Transducer, Miniature Pressure), a Class I device regulated under 21 CFR 890.1615. 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
Transducer, Miniature Pressure
Device Class
Class I
Regulation Number
890.1615
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)
  • K914776 — OXFORD PRESSURE MONITOR/TALLEY PRESSURE MONITOR (December 19, 1991)

Other clearances for product code IKE

  • K060125 — SONIC PALPOMETER (March 16, 2006)
  • K954670 — PRESSORE MONITOR (October 30, 1995)
  • K915369 — THE EQUALIZER (March 22, 1993)
  • K915326 — PORTABLE LIMB LOAD MONITOR (BMLLM-100) (October 20, 1992)
  • K920091 — IOWA ORAL PERFORMANCE ISNTRUMENT (May 20, 1992)
  • K915897 — FPL (April 7, 1992)
  • K902967 — MICRO-EMED-SYSTEM (September 17, 1990)
  • K880912 — DYNATRON 2000 (March 15, 1988)
  • K875103 — BIO-FEEDBACK LIMB MONITOR TYPE CODE BL-34-1 (January 20, 1988)
  • K871690 — EMED-F-SYSTEM (May 15, 1987)

FDA data resources