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510(k) K880912

DYNATRON 2000 by Dynatronics Corp. — Product Code IKE

K880912 is an FDA 510(k) premarket notification submitted by Dynatronics Corp. for the device "DYNATRON 2000". The FDA issued a decision of Substantially Equivalent on March 15, 1988. The device falls under product code IKE (Transducer, Miniature Pressure), a Class I device regulated under 21 CFR 890.1615. Dynatronics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1988
Date Received
March 3, 1988
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 Dynatronics Corp.

  • K132057 — DYNATRON PELTIER THERMOSTIM PROBE (January 24, 2014)
  • K113250 — DYNATRON TRI-WAVE LIGHT PAD DYNATRON TRI-WAVE LIGHT PROBE (February 9, 2012)
  • K060814 — DYNATRON ION IONTOPHORESIS ELECTRODE (June 14, 2006)
  • K051680 — DYNATRON DX2 TRACTION UNIT (October 11, 2005)
  • K051261 — DYNATRON X3 , DYNATRON XP IR LIGHT PAD, D405 IR LIGHT PROBE (July 25, 2005)
  • K043047 — DYNATRON IBOX IONTOPHORESIS DEVICE (January 7, 2005)
  • K040729 — SOLARIS D890 THERAPY PROBE (June 2, 2004)
  • K031329 — DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL (October 22, 2003)
  • K010948 — DYNATRON STS RX (May 15, 2001)
  • K010565 — DYNATRON STS (May 15, 2001)

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)
  • K914780 — TALLEY SD.500 SKIN PRESSURE EVALUATOR (December 19, 1991)
  • K902967 — MICRO-EMED-SYSTEM (September 17, 1990)
  • K875103 — BIO-FEEDBACK LIMB MONITOR TYPE CODE BL-34-1 (January 20, 1988)
  • K871690 — EMED-F-SYSTEM (May 15, 1987)

FDA data resources