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510(k) K920189

GX-C CEPHALOMETER by Gendex Corp. — Product Code EAG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1992
Date Received
January 15, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cephalometer
Device Class
Class II
Regulation Number
872.1830
Review Panel
RA
Submission Type

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Other clearances for product code EAG

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  • K021372 — VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABILITY (June 7, 2002)
  • K944162 — DENAR ACCUCEPH CEPHALOMETER IMAGING SYSTEM (November 29, 1994)
  • K896099 — DIGIGRAPH DIAGNOSTIC WORK/STATION (January 31, 1991)
  • K870243 — BURNETT TMJ APPLIANCE (February 24, 1987)
  • K842463 — GX CEPH (August 2, 1984)
  • K833006 — CEPHALOMETER & FIXATOR (January 3, 1984)
  • K810538 — PLASTICEPH (April 29, 1981)
  • K781287 — DENTAL X-RAY UNIT W/CEPHALOMETRIC ATTACH (September 11, 1978)