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510(k) K915138

GE SONOCHROME by GE Medical Systems — Product Code MAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1992
Date Received
November 13, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Fetal Doppler Ultrasound
Device Class
Class II
Regulation Number
884.2660
Review Panel
RA
Submission Type

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Other clearances for product code MAA

  • K102138 — ULTRASONIC TABLETOP DOPPLER; ULTRASONIC TABLETOP DOPPLER (October 28, 2010)
  • K090499 — LIFEDOP MODEL, L350R (March 31, 2009)
  • K905536 — FETAL DOPPLER (April 21, 1992)
  • K904600 — L582 TRANSDUCER (June 24, 1991)
  • K905456 — L328 TRANSDUCER (May 28, 1991)
  • K904951 — S5192R TRANSDUCER (April 29, 1991)
  • K895909 — SONICAID MODEL VASOFLO 4 (July 9, 1990)
  • K894992 — QUANTUM QAD ANGIODYNOGRAPH ULTRASOUND SYSTEM (February 23, 1990)