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510(k) K893225

COUPLANT WARMING DEVICE by Echo Ultrasound — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 1989
Date Received
April 27, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type

Other clearances by Echo Ultrasound

  • K924054 — PHONOCARDIOGRAPH (January 22, 1993)
  • K903414 — TRANSESOPHAGEAL PROBE HOLDER & DISINFECTING COLUMN (September 19, 1990)
  • K872519 — STERILIZED OMNI GEL (August 3, 1987)
  • K844120 — ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS (January 23, 1985)
  • K844034 — SONOCARE (January 23, 1985)

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