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510(k) K982651

COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER by Corometrics Medical Systems, Inc. — Product Code HEL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1998
Date Received
July 30, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Corometrics Medical Systems, Inc.

  • K905000 — ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER (January 31, 1991)
  • K903623 — MODEL600 UTERINE ACTIVITY MONITOR (November 7, 1990)
  • K891997 — CATALOG #2270AAX, 2270DAX BELTLESS TOCOTRANSDUCER (June 8, 1989)
  • K880900 — SSD-620 LINEAR/CONVEX ARRAY SECTOR SCANNER (June 1, 1988)

Other clearances for product code HEL

  • K003876 — US SENSOR #CG-930P; TOCO SENSOR CG-940P (July 9, 2001)
  • K010920 — TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING (June 22, 2001)
  • K971240 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M006 (June 6, 1997)
  • K930714 — SONICAID MODEL TEAM FECG IUP (August 24, 1995)
  • K933816 — SONICAID MODEL P110 FETAL HEAR DETECTOR (December 22, 1994)
  • K780035 — MINIVISOR (March 6, 1978)