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510(k) K944597

GRAHAM-FIELD ULTRASOUND SCANNING GEL by Chester Labs, Inc. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1995
Date Received
September 19, 1994
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 Chester Labs, Inc.

  • K041060 — E-Z LUBRICATING JELLY (May 7, 2004)
  • K001705 — STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MO (June 29, 2000)
  • K001593 — MODIFICATION TO STATSIGN SALINE ELECTROLYTE GEL, GRAHAM-FIELD SALINE ELECTROLYTE (June 14, 2000)
  • K944598 — GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL (May 7, 1996)
  • K944599 — GRAHAM-FIELD CONDUCTIVE ECG SPRAY (May 7, 1996)
  • K944600 — GRAHAM-FIELD SALINE ELECTROLYTE GEL (November 20, 1995)
  • K944596 — GRAHAM-FIELD ULTRASOUND LOTION (June 7, 1995)
  • K940254 — BIOSHIELD BLUE POWDER FREE GLOVE (March 23, 1994)
  • K940256 — BIOSHIELD BLUE LATEX GLOVES (March 23, 1994)
  • K841871 — LIQUA-SONIC GEL (March 14, 1985)

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