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510(k) K881133

70-X/RVG (RADIOVISIOGRAPHY) by Trophy Radiologie — Product Code EHO

K881133 is an FDA 510(k) premarket notification submitted by Trophy Radiologie for the device "70-X/RVG (RADIOVISIOGRAPHY)". The FDA issued a decision of Substantially Equivalent on July 20, 1989. The device falls under product code EHO (Bar, Preformed), a Class I device regulated under 21 CFR 872.3165. Trophy Radiologie has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1989
Date Received
March 16, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bar, Preformed
Device Class
Class I
Regulation Number
872.3165
Review Panel
DE
Submission Type

Other clearances by Trophy Radiologie

  • K033690 — TROPHYPAN AND TROPHYPAN C (February 20, 2004)
  • K033419 — STV PRO 2 (February 2, 2004)
  • K023346 — TROPHYPAN (January 3, 2003)
  • K012514 — DIGIPAN / DPI (December 21, 2001)
  • K991455 — ORTHOSLICE OS1000 SERIES; PANORAMIC ORTHOSLICE OS 1000: OS1000, OS1000E PANORAMI (June 25, 1999)
  • K991912 — MODIFICATION TO DIGIPAN (June 22, 1999)
  • K961826 — DIGIPAN (September 23, 1996)
  • K962337 — ELITYS OR ELITYS-E (July 25, 1996)
  • K953936 — ATLANTIS (December 28, 1995)
  • K951074 — STOMAVISION (STV) (September 19, 1995)

Other clearances for product code EHO

  • K934468 — SLIP-ON FIXATION SPLINT (SFS) (August 5, 1994)
  • K883388 — DENTREK BRIDGE BARS (October 6, 1988)

FDA data resources