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510(k) K844034

SONOCARE by Echo Ultrasound — Product Code DYO

K844034 is an FDA 510(k) premarket notification submitted by Echo Ultrasound for the device "SONOCARE". The FDA issued a decision of Substantially Equivalent on January 23, 1985. The device falls under product code DYO (Band, Material, Orthodontic), a Class I device regulated under 21 CFR 872.5410. Echo Ultrasound has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 1985
Date Received
October 16, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Band, Material, Orthodontic
Device Class
Class I
Regulation Number
872.5410
Review Panel
DE
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)
  • K844120 — ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS (January 23, 1985)

Other clearances for product code DYO

  • K935152 — DENTAURUM DENTAFORM BANDS, DENTAURUM STANDARD (January 31, 1994)
  • K931980 — STAINLESS STEEL ORTHODONTIC PRODUCTS (September 1, 1993)

FDA data resources