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510(k) K003458

SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000 by Clinical Innovations, Inc. — Product Code HGP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2001
Date Received
November 7, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Circular (Spiral), Scalp And Applicator
Device Class
Class II
Regulation Number
884.2675
Review Panel
OB
Submission Type

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Other clearances for product code HGP

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  • K910815 — CR SPIRAL ELECTRODE (December 10, 1991)
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  • K905830 — COMBO FETAL SCALP ELECTRODE/LEGPLATE (March 29, 1991)
  • K904745 — MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE (January 29, 1991)
  • K905130 — FETAL MONITORING SPIRAL ELECTRODE (January 29, 1991)
  • K901152 — REDYPLATE DISPOSABLE LEG PLATE (April 4, 1990)
  • K872057 — FETAL SCALP ELECTRODE (November 16, 1987)