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510(k) K920091

IOWA ORAL PERFORMANCE ISNTRUMENT by Breakthrough, Inc. — Product Code IKE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1992
Date Received
January 8, 1992
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

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  • K902967 — MICRO-EMED-SYSTEM (September 17, 1990)
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  • K875103 — BIO-FEEDBACK LIMB MONITOR TYPE CODE BL-34-1 (January 20, 1988)
  • K871690 — EMED-F-SYSTEM (May 15, 1987)