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510(k) K905545

ULTRASOUND TRANSMISSION GEL by Arbo Medical, Inc. — Product Code JOT

K905545 is an FDA 510(k) premarket notification submitted by Arbo Medical, Inc. for the device "ULTRASOUND TRANSMISSION GEL". The FDA issued a decision of Substantially Equivalent on March 29, 1991. The device falls under product code JOT (Electrode, Gel, Electrosurgical), a Class II device regulated under 21 CFR 878.4400. Arbo Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1991
Date Received
December 11, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Gel, Electrosurgical
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Other clearances by Arbo Medical, Inc.

  • K940323 — ARBO DIAGNOSTIC ECG PATIENT CABLES & LEADWIRES ARBO SHIELDED MULTI-LEAD CABLE & (April 12, 1995)
  • K935437 — ARBO H85V/H87V/H27V DISPOS MONIT ELECTRODES (April 6, 1995)
  • K942905 — DISPOSABLE TEMPERATURE PROBE COVER (February 27, 1995)
  • K940302 — ARBO MONITRING SAFETY CABLE & LEAD WIRE SYSTEMS/ARBO UNSHEILDED SAFETY CABLE & L (November 30, 1994)
  • K940322 — ARBO VS MONITOR CABLE & LEADWIRE SYSTEM ARBO SHIELDED SAFETY CABLE & LEAD WIRE (November 28, 1994)
  • K935246 — ARBO H49P, H59P DISPOSABLE MONITORING ELECTRODES (November 16, 1994)
  • K935429 — ARBO H90, H91, H135 DISPOSABLE MONITORING ELECTRODES (November 1, 1994)
  • K935281 — ARBO H87P, H85P, H27P DISPOSABLE MONITORING ELECTRODES (September 6, 1994)
  • K902788 — CLEM TM (September 12, 1990)
  • K901816 — PRESSURE TUBING AND ACCESSORIES (July 12, 1990)

Other clearances for product code JOT

  • K923647 — RFG-DGP DISPOSABLE GROUNDING PADS (November 9, 1992)
  • K904418 — ULTRASOUND COUPLING GEL (February 11, 1991)
  • K901217 — TRIA-SONIC ULTRA SOUND TRANSMISSION GEL (June 22, 1990)
  • K894490 — STERILE ULTRASOUND TRANSMISSION GEL (October 5, 1989)
  • K884503 — ULTRASONIC TRANSMISSION GEL (February 13, 1989)
  • K872519 — STERILIZED OMNI GEL (August 3, 1987)
  • K871565 — ULTRASOUND TRANSDUCER GEL, STERILE (July 15, 1987)
  • K800933 — R2 ELECTROSURG. RETURN ELECT. #225ETC. (May 20, 1980)

FDA data resources