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510(k) K060125

SONIC PALPOMETER by Palpometer Systems, Inc. — Product Code IKE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2006
Date Received
January 18, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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)
  • 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)