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510(k) K780035

MINIVISOR by Metrix Teknika, Inc. — Product Code HEL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1978
Date Received
January 9, 1978
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 Metrix Teknika, Inc.

  • K781803 — FILTER, EYRPUR DISPOSABLE LEUKOCITE (January 17, 1979)
  • K781802 — WASHER SYSTEM, MICROELISA (December 20, 1978)
  • K781348 — FOCISCAN ECHOVISOR SYSTEM (October 3, 1978)

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)
  • K982651 — COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER (December 11, 1998)
  • 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)