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510(k) K844120

ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS by Echo Ultrasound — Product Code GXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 1985
Date Received
October 23, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Block, Test, Ultrasonic Scanner Calibration
Device Class
Class I
Regulation Number
882.1925
Review Panel
NE
Submission Type

Other clearances by Echo Ultrasound

  • K924054 — PHONOCARDIOGRAPH (January 22, 1993)
  • K903414 — TRANSESOPHAGEAL PROBE HOLDER & DISINFECTING COLUMN (September 19, 1990)
  • K893225 — COUPLANT WARMING DEVICE (October 12, 1989)
  • K872519 — STERILIZED OMNI GEL (August 3, 1987)
  • K844034 — SONOCARE (January 23, 1985)

Other clearances for product code GXX

  • K893216 — RMI ULTRASOUND DOPPLER PHANTOM SYSTEM (September 5, 1989)
  • K844247 — ULTRASONIC SCANNER CALIBRATION & TEST PHANTOMS (January 23, 1985)