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510(k) K864499

PODOSCOPE by Broadwest Corp. — Product Code IKE

K864499 is an FDA 510(k) premarket notification submitted by Broadwest Corp. for the device "PODOSCOPE". The FDA issued a decision of Substantially Equivalent on February 4, 1987. The device falls under product code IKE (Transducer, Miniature Pressure), a Class I device regulated under 21 CFR 890.1615. Broadwest Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1987
Date Received
November 14, 1986
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 Broadwest Corp.

  • K864569 — PODODIGITAL (February 4, 1987)
  • K852302 — INOX IORCEPS JAR (July 2, 1985)
  • K852301 — INOX THERMOMETER JAR (July 1, 1985)
  • K852300 — INOX IV STAND (June 20, 1985)
  • K851307 — INOX DRY HEAT STERILIZER (May 9, 1985)

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)
  • K880912 — DYNATRON 2000 (March 15, 1988)
  • K875103 — BIO-FEEDBACK LIMB MONITOR TYPE CODE BL-34-1 (January 20, 1988)

FDA data resources