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510(k) K920056

POCKET SIZE FETAL HEART DETECTOR by Medical Accessories, Inc. — Product Code KNG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1992
Date Received
January 6, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Ultrasonic, Fetal
Device Class
Class II
Regulation Number
884.2660
Review Panel
OB
Submission Type

Other clearances by Medical Accessories, Inc.

  • K901152 — REDYPLATE DISPOSABLE LEG PLATE (April 4, 1990)
  • K872057 — FETAL SCALP ELECTRODE (November 16, 1987)

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  • K182710 — Fetal Doppler, Model FD88 (March 1, 2019)