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510(k) K843634

ASC 4080 SYSTEM by Atlantis Scientific Corp. — Product Code IKE

K843634 is an FDA 510(k) premarket notification submitted by Atlantis Scientific Corp. for the device "ASC 4080 SYSTEM". The FDA issued a decision of Substantially Equivalent on November 8, 1984. The device falls under product code IKE (Transducer, Miniature Pressure), a Class I device regulated under 21 CFR 890.1615.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 1984
Date Received
September 17, 1984
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 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